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Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Study Purpose

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-consolidation treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of delayed intensification. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 1 Year - 25 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to eligibility studies (Part A) prior to treatment and enrollment on AALL1732.
Note that central confirmation of MPAL diagnosis must occur within 22 days of enrollment for suspected MPAL patients. If not performed within this time frame, patients will be taken off protocol.
  • - APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1.
B-LLy patients may directly enroll on AALL1732.
  • - Patients must be > 365 days and < 25 years of age.
  • - White blood cell count (WBC) criteria for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy): - Age 1-9.99 years: WBC >= 50,000/uL.
  • - Age 10-24.99 years: Any WBC.
  • - Age 1-9.99 years: WBC < 50,000/uL with: - Testicular leukemia.
  • - CNS leukemia (CNS3) - Steroid pretreatment.
  • - White blood cell count (WBC) criteria for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy): - Age 1-24.99 years: any WBC NOTE: Patients enrolled as suspected MPAL but found on central confirmatory testing to have B-ALL must meet the B-ALL criteria above (age, WBC, extramedullary disease, steroid pretreatment) to switch to the B-ALL stratum before the end of induction.
  • - Patient has newly diagnosed B-ALL or MPAL (by World Health Organization [WHO] 2016 criteria) with >= 25% blasts on a bone marrow (BM) aspirate; - OR If a BM aspirate is not obtained or is not diagnostic of acute leukemia, the diagnosis can be established by a pathologic diagnosis of acute leukemia on a BM biopsy; - OR A complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells if a bone marrow aspirate or biopsy cannot be performed.
  • - Patient has newly diagnosed B-LLy Murphy stages III or IV.
  • - Patient has newly diagnosed B-LLy Murphy stages I or II with steroid pretreatment.
  • - Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL.
For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted.
  • - Central nervous system (CNS) status must be determined prior to enrollment based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment and cytoreduction.
It is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture. This is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture. This is allowed prior to enrollment. Systemic chemotherapy must begin within 72 hours of this intrathecal therapy.
  • - All patients and/or their parents or legal guardians must sign a written informed consent.
  • - All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met.

Exclusion Criteria:

  • - Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group).
  • - With the exception of steroid pretreatment and steroid cytoreduction or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732.
  • - Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy.
  • - Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells.
  • - Patients with acute undifferentiated leukemia (AUL) are not eligible.
  • - For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional exclusion criteria apply: - T-lymphoblastic lymphoma.
  • - Morphologically unclassifiable lymphoma.
  • - Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma.
  • - Patients with known Charcot-Marie-Tooth disease.
  • - Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
  • - Patients requiring radiation at diagnosis.
  • - Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs.
A pregnancy test is required for female patients of childbearing potential.
  • - Lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
  • - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation.
For those patients randomized to inotuzumab ozogamicin, there is a minimum of 8 months after the last dose of inotuzumab ozogamicin for females and 5 months after the last dose of inotuzumab ozogamicin for males.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03959085
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Children's Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jennifer L McNeer
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries Australia, Canada, New Zealand, Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma, Central Nervous System Leukemia, Mixed Phenotype Acute Leukemia, Testicular Leukemia
Additional Details

PRIMARY OBJECTIVE:

  • I. To compare in a randomized manner the 5-year disease-free survival (DFS) for children and young adults with High Risk (HR) B-cell acute lymphoblastic leukemia (B-ALL) treated with modified Berlin-Frankfurt-Munster (mBFM) chemotherapy without delayed intensification (DI) part 2, but with the addition of two blocks of inotuzumab ozogamicin, versus those treated with full mBFM chemotherapy backbone including DI Part 2 without the addition of inotuzumab ozogamicin.
SECONDARY OBJECTIVES:
  • I. To describe the 5-year DFS for a favorable risk subset of National Cancer Institute (NCI) HR B-ALL (HR-Fav) when treated with mBFM chemotherapy with a single high-dose methotrexate (HD-MTX) interim maintenance (IM) phase and treatment duration of 2 years from the start of IM regardless of sex.
  • II. To determine the toxicity and tolerability of inotuzumab ozogamicin integrated into the mBFM chemotherapy backbone in HR B-ALL including toxicity experienced during phases of therapy subsequent to inotuzumab ozogamicin.
  • III. To describe the 5-year event-free survival (EFS) for patients with mixed phenotype acute leukemia (MPAL) receiving mBFM HR B-ALL therapy that includes a second IM phase with Capizzi intravenous (IV) methotrexate without leucovorin rescue plus pegaspargase or calaspargase pegol (C-MTX).
  • IV. To describe the 5-year EFS for patients with disseminated (Murphy stage III-IV) B-cell lymphoblastic lymphoma (B-LLy) receiving mBFM HR B-ALL therapy that includes a second IM phase with C-MTX.
EXPLORATORY OBJECTIVES:
  • I. To describe the therapy administered, disease response, and survival outcomes of patients with MPAL who come off protocol therapy due to poor disease response to ALL therapy either during Induction, at end of induction (EOI), or at end of consolidation (EOC).
  • II. To define the prevalence and significance of minimal marrow disease (MMD) at diagnosis and bone marrow minimal residual disease (MRD) at EOI in disseminated B-LLy.
  • III. To determine the impact of proposed adherence-enhancing interventions on adherence to oral 6-mercaptopurine in patients with ALL.
OUTLINE: All patients receive the same Induction and Consolidation chemotherapy. Patients with HR-Fav B-ALL are assigned to Arm
  • I. Patients with HR B-ALL are randomized to Arm II or III.
Patients with MPAL are assigned to Arm IV, and patients with B-LLy are assigned to Arm
  • V. All patients with B-ALL receive Induction and Consolidation therapy: INDUCTION: Patients receive cytarabine intrathecally (IT) on day 1 and central nervous system (CNS)2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12.
Patients also receive vincristine intravenously (IV) on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase intramuscularly (IM) on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone orally (PO) twice daily (BID) or IV on days 1-14; patients >= 10 years old receive prednis(ol)one PO BID or IV on days 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO once daily (QD) on days 1-14 and 29-42, and methotrexate IT on days 1, 8, 15, and 22 (CNS3 patients receive methotrexate IT on days 1 and 8). Patients also receive vincristine IV on days 15, 22, 43, and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients with testicular disease at diagnosis that does not resolve by the end of induction will undergo radiation therapy over 12 once daily fractions. Calaspargase pegol can only be given to patients less than 22 years of age. POST-CONSOLIDATION THERAPY: After Consolidation, based on clinical features and response, patients with B-ALL are designated as HR-Fav or HR B-ALL. Patients with HR-Fav B-ALL are assigned to Arm
  • I. Patients with HR B-ALL are randomized to Arm II or III.
Patients with MPAL and B-LLy are assigned to therapy arms (Arms IV and V) that are identical to Arm
  • II. Patients that are < 10 years, have CNS1, no testicular leukemia, with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks prior to diagnosis, and EOI MRD < 0.01% are assigned to Arm I.
Patients with HR B-ALL who are surface CD22 positive at diagnosis and have MRD < 0.01% by the end of Consolidation, are randomized to either Arm II or
  • III. ARM I: HR-FAV B-ALL (Patients that are < 10 years, have CNS1 status, no testicular leukemia, with favorable cytogenetics (ETV6 RUNX1 fusion or double trisomies [4 and 10]), =< 24 hours of steroids in the two weeks prior to diagnosis, and EOI MRD < 0.01%) INTERIM MAINTENANCE: Patients receive vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29.
Treatment continues for 9 weeks in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 43. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. MAINTENANCE: Patients receive methotrexate IT on days 1 and 29 for cycles 1-4, and day 1 for subsequent cycles. Patients also receive vincristine IV on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO QD on days 1-84, and methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1-4), 36, 43, 50, 57, 64, 71, and 78. Cycles repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients with HR B-ALL who have MRD < 0.01% by the end of Consolidation, and leukemic blasts positive for surface CD22 at diagnosis are randomized to Arm II or Arm
  • III. ARM II: HR B-ALL (CONTROL) INTERIM MAINTENANCE I: Patients receive vincristine IV on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29 and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, 45-46, mercaptopurine PO QD on days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29.
Treatment continues for 9 weeks in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 43. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. INTERIM MAINTENANCE II: Patients receive vincristine on days 1, 11, 21, 31 and 41, methotrexate IV over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 (pegaspargase) or 23 (calaspargase) or pegaspargase IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. ARM III: HR B-ALL (EXPERIMENTAL) INOTUZUMAB OZOGAMICIN (InO) BLOCK 1: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15 and methotrexate IT on day 1. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. INTERIM MAINTENANCE I: Patients receive vincristine IV on days 1, 15, 29 and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, mercaptopurine PO on days 1-14, 15-28, 29-42, and 43-56, and methotrexate IT on days 1 and 29. Treatment continues for 9 weeks in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION (Part I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed Intensification) continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. InO BLOCK 2: Patients receive inotuzumab ozogamicin IV over 60 minutes on days 1, 8, and 15. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. INTERIM MAINTENANCE II: Patients receive vincristine IV on days 1, 11, 21, 31, and 41, methotrexate IV on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 (pegaspargase) or 23 (calaspargase) or pegaspargase IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. ARMS II AND III: HR B-ALL MAINTENANCE: Patients receive vincristine IV on day 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71 and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients with CNS3 disease undergo cranial radiation therapy over 10 fractions during the first 4 weeks. ARM IV: MPAL INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22 for CNS3 patients), vincristine IV on days 15, 22, 43, and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with testicular disease at diagnosis that does not resolve by the end of induction will and continued evidence of testicular disease at end of induction undergo testicular radiation over 12 once-daily fractions. Calaspargase pegol can only be given to patients less than 22 years of age. ARM V: B-LLY INDUCTION: Patients receive cytarabine IT on day 1 and CNS2 patients also receive cytarabine IT on days 4, 5 or 6 and 11 or 12. Patients also receive vincristine IV on days 1, 8, 15, and 22, daunorubicin IV over 1-15 minutes days 1, 8, 15, and 22, pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4, and methotrexate IT on days 8 and 29 (and on days 15 and 22 for CNS3 patients). Patients < 10 years old receive dexamethasone PO BID or IV on days 1-14; patients >= 10 years old receive prednisolone PO BID or IV on days 1-28. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. CONSOLIDATION: Patients receive cyclophosphamide IV over 30-60 minutes on days 1 and 29, cytarabine IV over 1-30 minutes or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, methotrexate IT on days 1, 8, 15, and 22 (excluded on days 15 and 22 CNS3 patients), vincristine IV on days 15, 22, 43, and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on days 15 and 43. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with testicular disease at diagnosis that does not resolve by the end of induction will and continued evidence of testicular disease at end of induction undergo testicular radiation therapy over 12 once-daily fractions. Calaspargase pegol can only be given to patients less than 22 years of age. ARM IV AND V: MPAL AND B-LLY (Post-Consolidation Therapy) INTERIM MAINTENANCE I: Patients receive vincristine IV on days 1, 15, 29, and 43, high dose methotrexate IV over 24 hours on days 1, 15, 29, and 43, leucovorin PO or IV on days 3-4, 17-18, 31-32, and 45-46, methotrexate IT on days 1 and 29 and mercaptopurine PO QD on days 1-14, 15-28, 29-42, and 43-56. Treatment continues for 9 weeks in the absence of disease progression or unacceptable toxicity. DELAYED INTENSIFICATION (PART I): Patients receive methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, doxorubicin IV over 1-15 minutes or up to 1 hour on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 4. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. DELAYED INTENSIFICATION (PART II): Patients receive cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36, vincristine IV or IV push over 1 minute on days 43 and 50, and pegaspargase or calaspargase pegol IV over 1-2 hours or pegaspargase IM on day 43. Treatment (Parts I and II of Delayed Intensification) continues for 9 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. INTERIM MAINTENANCE II: Patients receive vincristine IV on days 1, 11, 21, 31, and 41, methotrexate IV or infusion over 2-15 minutes or 10-15 minutes on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or calaspargase pegol IV over 1-2 hours on days 2 and 22 (pegaspargase) or (calaspargase) 23 or pegaspargase IM on days 2 and 22. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Calaspargase pegol can only be given to patients less than 22 years of age. MAINTENANCE: Patients receive vincristine IV on days 1, prednisolone PO BID or IV on days 1-5, mercaptopurine PO on days 1-84, methotrexate PO on days 8, 15, 22, 29 (excluded in cycles 1 and 2), 36, 43, 50, 57, 64, 71, and 78, and methotrexate IT on days 1 (and 29 of cycles 1-2 for patients who do not receive cranial radiation). Cycles repeat every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients with CNS3 disease at diagnosis undergo cranial radiation therapy for 10 fractions over 4 weeks. Patients undergo blood sample collection and bone marrow aspiration and biopsy on study. B-LLy patients undergo computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and/or bone scan on study. After completion of study treatment, patients are followed up at 4 weeks, then every 3 months for 2 years, every 4-6 months for the third year, then every 6-12 months for years 4-5.

Arms & Interventions

Arms

Experimental: Arm I (HR-FAV B-ALL)

See detailed description for Arm I

Active Comparator: Arm II (HR B-ALL CONTROL)

See detailed description for Arm II.

Experimental: Arm III (HR B-ALL EXPERIMENTAL)

See detailed description for Arm III.

Experimental: Arm IV (MPAL)

See detailed description for Arm IV.

Experimental: ARM V (B-LLY)

See detailed description for Arm V.

Interventions

Procedure: - Biospecimen Collection

Undergo blood sample collection

Procedure: - Bone Marrow Aspiration

Undergo bone marrow aspiration

Procedure: - Bone Marrow Biopsy

Undergo bone marrow biopsy

Procedure: - Bone Scan

Undergo bone scan

Drug: - Calaspargase Pegol

Given IV

Procedure: - Computed Tomography

Undergo CT

Drug: - Cyclophosphamide

Given IV

Drug: - Cytarabine

Given IV, IT, or SC

Drug: - Daunorubicin Hydrochloride

Given IV

Drug: - Dexamethasone

Given PO or IV

Drug: - Doxorubicin Hydrochloride

Given IV

Biological: - Inotuzumab Ozogamicin

Given IV

Drug: - Leucovorin Calcium

Given PO or IV

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Drug: - Mercaptopurine

Given PO

Drug: - Methotrexate

Given IT or IV

Drug: - Pegaspargase

Given IV or IM

Procedure: - Positron Emission Tomography

Undergo PET

Drug: - Prednisolone

Given PO or IV

Other: - Questionnaire Administration

Ancillary studies

Radiation: - Radiation Therapy

Undergo testicular radiation therapy

Radiation: - Radiation Therapy

Undergo cranial radiation therapy

Drug: - Thioguanine

Given PO

Drug: - Vincristine Sulfate

Given IV

Contact a Trial Team

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Children's Hospital of Alabama, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

Children's Hospital of Alabama

Birmingham 4049979, Alabama 4829764, 35233

Site Contact

Site Public Contact

[email protected]

205-638-9285

USA Health Strada Patient Care Center, Mobile 4076598, Alabama 4829764

Status

Recruiting

Address

USA Health Strada Patient Care Center

Mobile 4076598, Alabama 4829764, 36604

Site Contact

Site Public Contact

800-388-8721

Providence Alaska Medical Center, Anchorage 5879400, Alaska 5879092

Status

Recruiting

Address

Providence Alaska Medical Center

Anchorage 5879400, Alaska 5879092, 99508

Site Contact

Site Public Contact

[email protected]

907-212-6871

Banner Children's at Desert, Mesa 5304391, Arizona 5551752

Status

Recruiting

Address

Banner Children's at Desert

Mesa 5304391, Arizona 5551752, 85202

Site Contact

Site Public Contact

480-412-3100

Phoenix Childrens Hospital, Phoenix 5308655, Arizona 5551752

Status

Recruiting

Address

Phoenix Childrens Hospital

Phoenix 5308655, Arizona 5551752, 85016

Site Contact

Site Public Contact

602-546-0920

Tucson 5318313, Arizona 5551752

Status

Recruiting

Address

Banner University Medical Center - Tucson

Tucson 5318313, Arizona 5551752, 85719

Site Contact

Site Public Contact

[email protected]

Arkansas Children's Hospital, Little Rock 4119403, Arkansas 4099753

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock 4119403, Arkansas 4099753, 72202-3591

Site Contact

Site Public Contact

501-364-7373

Kaiser Permanente Downey Medical Center, Downey 5343858, California 5332921

Status

Recruiting

Address

Kaiser Permanente Downey Medical Center

Downey 5343858, California 5332921, 90242

Site Contact

Site Public Contact

626-564-3455

City of Hope Comprehensive Cancer Center, Duarte 5344147, California 5332921

Status

Recruiting

Address

City of Hope Comprehensive Cancer Center

Duarte 5344147, California 5332921, 91010

Site Contact

Site Public Contact

[email protected]

800-826-4673

Loma Linda University Medical Center, Loma Linda 5367696, California 5332921

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda 5367696, California 5332921, 92354

Site Contact

Site Public Contact

909-558-4050

Long Beach 5367929, California 5332921

Status

Recruiting

Address

Miller Children's and Women's Hospital Long Beach

Long Beach 5367929, California 5332921, 90806

Site Contact

Site Public Contact

562-933-5600

Children's Hospital Los Angeles, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles 5368361, California 5332921, 90027

Site Contact

Site Public Contact

323-361-4110

Cedars Sinai Medical Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles 5368361, California 5332921, 90048

Site Contact

Site Public Contact

310-423-8965

Mattel Children's Hospital UCLA, Los Angeles 5368361, California 5332921

Status

Suspended

Address

Mattel Children's Hospital UCLA

Los Angeles 5368361, California 5332921, 90095

Valley Children's Hospital, Madera 5369568, California 5332921

Status

Recruiting

Address

Valley Children's Hospital

Madera 5369568, California 5332921, 93636

Site Contact

Site Public Contact

[email protected]

559-353-3000

UCSF Benioff Children's Hospital Oakland, Oakland 5378538, California 5332921

Status

Recruiting

Address

UCSF Benioff Children's Hospital Oakland

Oakland 5378538, California 5332921, 94609

Site Contact

Site Public Contact

[email protected]

510-428-3264

Kaiser Permanente-Oakland, Oakland 5378538, California 5332921

Status

Recruiting

Address

Kaiser Permanente-Oakland

Oakland 5378538, California 5332921, 94611

Site Contact

Site Public Contact

[email protected]

877-642-4691

Children's Hospital of Orange County, Orange 5379513, California 5332921

Status

Recruiting

Address

Children's Hospital of Orange County

Orange 5379513, California 5332921, 92868

Site Contact

Site Public Contact

[email protected]

714-509-8646

Palo Alto 5380748, California 5332921

Status

Recruiting

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto 5380748, California 5332921, 94304

Site Contact

Site Public Contact

[email protected]

800-694-0012

Sutter Medical Center Sacramento, Sacramento 5389489, California 5332921

Status

Suspended

Address

Sutter Medical Center Sacramento

Sacramento 5389489, California 5332921, 95816

Sacramento 5389489, California 5332921

Status

Recruiting

Address

University of California Davis Comprehensive Cancer Center

Sacramento 5389489, California 5332921, 95817

Site Contact

Site Public Contact

916-734-3089

Rady Children's Hospital - San Diego, San Diego 5391811, California 5332921

Status

Recruiting

Address

Rady Children's Hospital - San Diego

San Diego 5391811, California 5332921, 92123

Site Contact

Site Public Contact

858-966-5934

Naval Medical Center -San Diego, San Diego 5391811, California 5332921

Status

Recruiting

Address

Naval Medical Center -San Diego

San Diego 5391811, California 5332921, 92134

Site Contact

Site Public Contact

619-532-8712

UCSF Medical Center-Mission Bay, San Francisco 5391959, California 5332921

Status

Recruiting

Address

UCSF Medical Center-Mission Bay

San Francisco 5391959, California 5332921, 94158

Site Contact

Site Public Contact

[email protected]

877-827-3222

Santa Barbara Cottage Hospital, Santa Barbara 5392952, California 5332921

Status

Recruiting

Address

Santa Barbara Cottage Hospital

Santa Barbara 5392952, California 5332921, 93102

Site Contact

Site Public Contact

805-682-7300

Torrance 5403022, California 5332921

Status

Active, not recruiting

Address

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance 5403022, California 5332921, 90502

Children's Hospital Colorado, Aurora 5412347, Colorado 5417618

Status

Recruiting

Address

Children's Hospital Colorado

Aurora 5412347, Colorado 5417618, 80045

Site Contact

Site Public Contact

[email protected]

303-764-5056

Denver 5419384, Colorado 5417618

Status

Recruiting

Address

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver 5419384, Colorado 5417618, 80218

Site Contact

Site Public Contact

[email protected]

303-832-2344

Connecticut Children's Medical Center, Hartford 4835797, Connecticut 4831725

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford 4835797, Connecticut 4831725, 06106

Site Contact

Site Public Contact

860-545-9981

Yale University, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale University

New Haven 4839366, Connecticut 4831725, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Alfred I duPont Hospital for Children, Wilmington 4145381, Delaware 4142224

Status

Recruiting

Address

Alfred I duPont Hospital for Children

Wilmington 4145381, Delaware 4142224, 19803

Site Contact

Site Public Contact

[email protected]

302-651-5572

MedStar Georgetown University Hospital, Washington D.C. 4140963, District of Columbia 4138106

Status

Suspended

Address

MedStar Georgetown University Hospital

Washington D.C. 4140963, District of Columbia 4138106, 20007

Children's National Medical Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Recruiting

Address

Children's National Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20010

Site Contact

Site Public Contact

[email protected]

202-476-2800

Broward Health Medical Center, Fort Lauderdale 4155966, Florida 4155751

Status

Recruiting

Address

Broward Health Medical Center

Fort Lauderdale 4155966, Florida 4155751, 33316

Site Contact

Site Public Contact

[email protected]

302-651-5572

Fort Myers 4155995, Florida 4155751

Status

Recruiting

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers 4155995, Florida 4155751, 33908

Site Contact

Site Public Contact

[email protected]

239-343-5333

Gainesville 4156404, Florida 4155751

Status

Recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville 4156404, Florida 4155751, 32610

Site Contact

Site Public Contact

[email protected]

352-273-8010

Hollywood 4158928, Florida 4155751

Status

Recruiting

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood 4158928, Florida 4155751, 33021

Site Contact

Site Public Contact

[email protected]

954-265-1847

Nemours Children's Clinic-Jacksonville, Jacksonville 4160021, Florida 4155751

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville 4160021, Florida 4155751, 32207

Site Contact

Site Public Contact

[email protected]

302-651-5572

Palms West Radiation Therapy, Loxahatchee Groves 4162948, Florida 4155751

Status

Active, not recruiting

Address

Palms West Radiation Therapy

Loxahatchee Groves 4162948, Florida 4155751, 33470

Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami 4164138, Florida 4155751, 33136

Site Contact

Site Public Contact

305-243-2647

Nicklaus Children's Hospital, Miami 4164138, Florida 4155751

Status

Recruiting

Address

Nicklaus Children's Hospital

Miami 4164138, Florida 4155751, 33155

Site Contact

Site Public Contact

888-624-2778

Miami Cancer Institute, Miami 4164138, Florida 4155751

Status

Suspended

Address

Miami Cancer Institute

Miami 4164138, Florida 4155751, 33176

AdventHealth Orlando, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

AdventHealth Orlando

Orlando 4167147, Florida 4155751, 32803

Site Contact

Site Public Contact

[email protected]

407-303-2090

Arnold Palmer Hospital for Children, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando 4167147, Florida 4155751, 32806

Site Contact

Site Public Contact

[email protected]

321-841-5357

Nemours Children's Hospital, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Nemours Children's Hospital

Orlando 4167147, Florida 4155751, 32827

Site Contact

Site Public Contact

[email protected]

302-651-5572

Nemours Children's Clinic - Pensacola, Pensacola 4168228, Florida 4155751

Status

Recruiting

Address

Nemours Children's Clinic - Pensacola

Pensacola 4168228, Florida 4155751, 32504

Site Contact

Site Public Contact

[email protected]

Sacred Heart Hospital, Pensacola 4168228, Florida 4155751

Status

Suspended

Address

Sacred Heart Hospital

Pensacola 4168228, Florida 4155751, 32504

Johns Hopkins All Children's Hospital, St. Petersburg 4171563, Florida 4155751

Status

Recruiting

Address

Johns Hopkins All Children's Hospital

St. Petersburg 4171563, Florida 4155751, 33701

Site Contact

Site Public Contact

[email protected]

727-767-4784

Tampa General Hospital, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Tampa General Hospital

Tampa 4174757, Florida 4155751, 33606

Site Contact

Site Public Contact

[email protected]

813-844-7829

Tampa 4174757, Florida 4155751

Status

Recruiting

Address

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa 4174757, Florida 4155751, 33607

Site Contact

Site Public Contact

[email protected]

813-357-0849

Saint Mary's Medical Center, West Palm Beach 4177887, Florida 4155751

Status

Recruiting

Address

Saint Mary's Medical Center

West Palm Beach 4177887, Florida 4155751, 33407

Site Contact

Site Public Contact

561-822-4745

Atlanta 4180439, Georgia 4197000

Status

Recruiting

Address

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta 4180439, Georgia 4197000, 30329

Site Contact

Site Public Contact

[email protected]

404-785-0232

Augusta University Medical Center, Augusta 4180531, Georgia 4197000

Status

Recruiting

Address

Augusta University Medical Center

Augusta 4180531, Georgia 4197000, 30912

Site Contact

Site Public Contact

[email protected]

706-721-2388

Atrium Health Navicent, Macon 4207400, Georgia 4197000

Status

Recruiting

Address

Atrium Health Navicent

Macon 4207400, Georgia 4197000, 31201

Site Contact

Site Public Contact

[email protected]

478-633-2152

Savannah 4221552, Georgia 4197000

Status

Recruiting

Address

Memorial Health University Medical Center

Savannah 4221552, Georgia 4197000, 31404

Site Contact

Site Public Contact

[email protected]

912-350-7887

Honolulu 5856195, Hawaii 5855797

Status

Suspended

Address

Kapiolani Medical Center for Women and Children

Honolulu 5856195, Hawaii 5855797, 96826

Saint Luke's Cancer Institute - Boise, Boise 5586437, Idaho 5596512

Status

Recruiting

Address

Saint Luke's Cancer Institute - Boise

Boise 5586437, Idaho 5596512, 83712

Site Contact

Site Public Contact

[email protected]

208-381-2774

Lurie Children's Hospital-Chicago, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

Lurie Children's Hospital-Chicago

Chicago 4887398, Illinois 4896861, 60611

Site Contact

Site Public Contact

773-880-4562

University of Illinois, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Illinois

Chicago 4887398, Illinois 4896861, 60612

Site Contact

Site Public Contact

312-355-3046

Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center

Chicago 4887398, Illinois 4896861, 60637

Site Contact

Site Public Contact

[email protected]

773-702-8222

Loyola University Medical Center, Maywood 4901514, Illinois 4896861

Status

Recruiting

Address

Loyola University Medical Center

Maywood 4901514, Illinois 4896861, 60153

Site Contact

Site Public Contact

708-226-4357

Advocate Children's Hospital-Oak Lawn, Oak Lawn 4904365, Illinois 4896861

Status

Recruiting

Address

Advocate Children's Hospital-Oak Lawn

Oak Lawn 4904365, Illinois 4896861, 60453

Site Contact

Site Public Contact

847-723-7570

Advocate Children's Hospital-Park Ridge, Park Ridge 4905367, Illinois 4896861

Status

Recruiting

Address

Advocate Children's Hospital-Park Ridge

Park Ridge 4905367, Illinois 4896861, 60068

Site Contact

Site Public Contact

[email protected]

Saint Jude Midwest Affiliate, Peoria 4905687, Illinois 4896861

Status

Recruiting

Address

Saint Jude Midwest Affiliate

Peoria 4905687, Illinois 4896861, 61637

Site Contact

Site Public Contact

888-226-4343

Springfield 4250542, Illinois 4896861

Status

Suspended

Address

Southern Illinois University School of Medicine

Springfield 4250542, Illinois 4896861, 62702

Winfield 4916826, Illinois 4896861

Status

Recruiting

Address

Northwestern Medicine Central DuPage Hospital

Winfield 4916826, Illinois 4896861, 60190

Site Contact

Site Public Contact

[email protected]

630-315-1918

Riley Hospital for Children, Indianapolis 4259418, Indiana 4921868

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis 4259418, Indiana 4921868, 46202

Site Contact

Site Public Contact

800-248-1199

Indianapolis 4259418, Indiana 4921868

Status

Recruiting

Address

Ascension Saint Vincent Indianapolis Hospital

Indianapolis 4259418, Indiana 4921868, 46260

Site Contact

Site Public Contact

[email protected]

317-338-2194

Blank Children's Hospital, Des Moines 4853828, Iowa 4862182

Status

Recruiting

Address

Blank Children's Hospital

Des Moines 4853828, Iowa 4862182, 50309

Site Contact

Site Public Contact

[email protected]

515-241-8912

Iowa City 4862034, Iowa 4862182

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City 4862034, Iowa 4862182, 52242

Site Contact

Site Public Contact

800-237-1225

Wesley Medical Center, Wichita 4281730, Kansas 4273857

Status

Recruiting

Address

Wesley Medical Center

Wichita 4281730, Kansas 4273857, 67214

Site Contact

Site Public Contact

[email protected]

316-962-7802

Lexington 4297983, Kentucky 6254925

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington 4297983, Kentucky 6254925, 40536

Site Contact

Site Public Contact

859-257-3379

Norton Children's Hospital, Louisville 4299276, Kentucky 6254925

Status

Recruiting

Address

Norton Children's Hospital

Louisville 4299276, Kentucky 6254925, 40202

Site Contact

Site Public Contact

[email protected]

502-629-5500

Children's Hospital New Orleans, New Orleans 4335045, Louisiana 4331987

Status

Recruiting

Address

Children's Hospital New Orleans

New Orleans 4335045, Louisiana 4331987, 70118

Site Contact

Site Public Contact

504-894-5377

Ochsner Medical Center Jefferson, New Orleans 4335045, Louisiana 4331987

Status

Recruiting

Address

Ochsner Medical Center Jefferson

New Orleans 4335045, Louisiana 4331987, 70121

Site Contact

Site Public Contact

[email protected]

504-842-8084

Eastern Maine Medical Center, Bangor 4957280, Maine 4971068

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor 4957280, Maine 4971068, 04401

Site Contact

Site Public Contact

207-973-4274

Maine Children's Cancer Program, Scarborough 4977882, Maine 4971068

Status

Recruiting

Address

Maine Children's Cancer Program

Scarborough 4977882, Maine 4971068, 04074

Site Contact

Site Public Contact

[email protected]

207-396-8670

Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

University of Maryland/Greenebaum Cancer Center

Baltimore 4347778, Maryland 4361885, 21201

Site Contact

Site Public Contact

800-888-8823

Sinai Hospital of Baltimore, Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

Sinai Hospital of Baltimore

Baltimore 4347778, Maryland 4361885, 21215

Site Contact

Site Public Contact

410-601-9083

Baltimore 4347778, Maryland 4361885

Status

Recruiting

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore 4347778, Maryland 4361885, 21287

Site Contact

Site Public Contact

[email protected]

410-955-8804

Bethesda 4348599, Maryland 4361885

Status

Suspended

Address

Walter Reed National Military Medical Center

Bethesda 4348599, Maryland 4361885, 20889-5600

Tufts Children's Hospital, Boston 4930956, Massachusetts 6254926

Status

Active, not recruiting

Address

Tufts Children's Hospital

Boston 4930956, Massachusetts 6254926, 02111

Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston 4930956, Massachusetts 6254926, 02114

Site Contact

Site Public Contact

877-726-5130

Dana-Farber Cancer Institute, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

Site Public Contact

877-442-3324

Baystate Medical Center, Springfield 4951788, Massachusetts 6254926

Status

Recruiting

Address

Baystate Medical Center

Springfield 4951788, Massachusetts 6254926, 01199

Site Contact

Site Public Contact

[email protected]

413-794-3565

Worcester 4956184, Massachusetts 6254926

Status

Recruiting

Address

UMass Memorial Medical Center - University Campus

Worcester 4956184, Massachusetts 6254926, 01655

Site Contact

Site Public Contact

[email protected]

508-856-3216

C S Mott Children's Hospital, Ann Arbor 4984247, Michigan 5001836

Status

Recruiting

Address

C S Mott Children's Hospital

Ann Arbor 4984247, Michigan 5001836, 48109

Site Contact

Site Public Contact

800-865-1125

Children's Hospital of Michigan, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Children's Hospital of Michigan

Detroit 4990729, Michigan 5001836, 48201

Site Contact

Site Public Contact

[email protected]

Henry Ford Health Saint John Hospital, Detroit 4990729, Michigan 5001836

Status

Active, not recruiting

Address

Henry Ford Health Saint John Hospital

Detroit 4990729, Michigan 5001836, 48236

Michigan State University, East Lansing 4991640, Michigan 5001836

Status

Active, not recruiting

Address

Michigan State University

East Lansing 4991640, Michigan 5001836, 48823

Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids 4994358, Michigan 5001836, 49503

Site Contact

Site Public Contact

[email protected]

616-391-1230

Bronson Methodist Hospital, Kalamazoo 4997787, Michigan 5001836

Status

Recruiting

Address

Bronson Methodist Hospital

Kalamazoo 4997787, Michigan 5001836, 49007

Site Contact

Site Public Contact

[email protected]

616-391-1230

Corewell Health Children's, Royal Oak 5007804, Michigan 5001836

Status

Recruiting

Address

Corewell Health Children's

Royal Oak 5007804, Michigan 5001836, 48073

Site Contact

Site Public Contact

248-551-7695

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis 5037649, Minnesota 5037779, 55404

Site Contact

Site Public Contact

[email protected]

612-813-5913

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

University of Minnesota/Masonic Cancer Center

Minneapolis 5037649, Minnesota 5037779, 55455

Site Contact

Site Public Contact

612-624-2620

Mayo Clinic in Rochester, Rochester 5043473, Minnesota 5037779

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester 5043473, Minnesota 5037779, 55905

Site Contact

Site Public Contact

855-776-0015

University of Mississippi Medical Center, Jackson 4431410, Mississippi 4436296

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson 4431410, Mississippi 4436296, 39216

Site Contact

Site Public Contact

601-815-6700

Columbia 4381982, Missouri 4398678

Status

Recruiting

Address

University of Missouri Children's Hospital

Columbia 4381982, Missouri 4398678, 65212

Site Contact

Site Public Contact

[email protected]

573-882-1960

Children's Mercy Hospitals and Clinics, Kansas City 4393217, Missouri 4398678

Status

Recruiting

Address

Children's Mercy Hospitals and Clinics

Kansas City 4393217, Missouri 4398678, 64108

Site Contact

Site Public Contact

[email protected]

816-302-6808

St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Cardinal Glennon Children's Medical Center

St Louis 4407066, Missouri 4398678, 63104

Site Contact

Site Public Contact

314-268-4000

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63110

Site Contact

Site Public Contact

[email protected]

800-600-3606

Mercy Hospital Saint Louis, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Mercy Hospital Saint Louis

St Louis 4407066, Missouri 4398678, 63141

Site Contact

Site Public Contact

314-251-7066

Omaha 5074472, Nebraska 5073708

Status

Recruiting

Address

Children's Hospital and Medical Center of Omaha

Omaha 5074472, Nebraska 5073708, 68114

Site Contact

Site Public Contact

402-955-3949

University of Nebraska Medical Center, Omaha 5074472, Nebraska 5073708

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha 5074472, Nebraska 5073708, 68198

Site Contact

Site Public Contact

[email protected]

402-559-6941

Las Vegas 5506956, Nevada 5509151

Status

Suspended

Address

University Medical Center of Southern Nevada

Las Vegas 5506956, Nevada 5509151, 89102

Sunrise Hospital and Medical Center, Las Vegas 5506956, Nevada 5509151

Status

Suspended

Address

Sunrise Hospital and Medical Center

Las Vegas 5506956, Nevada 5509151, 89109

Las Vegas 5506956, Nevada 5509151

Status

Recruiting

Address

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas 5506956, Nevada 5509151, 89135

Site Contact

Site Public Contact

[email protected]

702-384-0013

Summerlin Hospital Medical Center, Las Vegas 5506956, Nevada 5509151

Status

Recruiting

Address

Summerlin Hospital Medical Center

Las Vegas 5506956, Nevada 5509151, 89144

Site Contact

Site Public Contact

[email protected]

702-384-0013

Renown Regional Medical Center, Reno 5511077, Nevada 5509151

Status

Recruiting

Address

Renown Regional Medical Center

Reno 5511077, Nevada 5509151, 89502

Site Contact

Site Public Contact

[email protected]

702-384-0013

Lebanon 5088597, New Hampshire 5090174

Status

Recruiting

Address

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon 5088597, New Hampshire 5090174, 03756

Site Contact

Site Public Contact

[email protected]

800-639-6918

Hackensack University Medical Center, Hackensack 5098706, New Jersey 5101760

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack 5098706, New Jersey 5101760, 07601

Site Contact

Site Public Contact

551-996-2897

Morristown Medical Center, Morristown 5101427, New Jersey 5101760

Status

Recruiting

Address

Morristown Medical Center

Morristown 5101427, New Jersey 5101760, 07960

Site Contact

Site Public Contact

973-971-5900

Jersey Shore Medical Center, Neptune City 5101687, New Jersey 5101760

Status

Recruiting

Address

Jersey Shore Medical Center

Neptune City 5101687, New Jersey 5101760, 07753

Site Contact

Site Public Contact

732-776-4240

Saint Peter's University Hospital, New Brunswick 5101717, New Jersey 5101760

Status

Recruiting

Address

Saint Peter's University Hospital

New Brunswick 5101717, New Jersey 5101760, 08901

Site Contact

Site Public Contact

[email protected]

732-745-8600 #6163

New Brunswick 5101717, New Jersey 5101760

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

New Brunswick 5101717, New Jersey 5101760, 08903

Site Contact

Site Public Contact

732-235-8675

Newark Beth Israel Medical Center, Newark 5101798, New Jersey 5101760

Status

Recruiting

Address

Newark Beth Israel Medical Center

Newark 5101798, New Jersey 5101760, 07112

Site Contact

Site Public Contact

[email protected]

973-926-7230

Saint Joseph's Regional Medical Center, Paterson 5102466, New Jersey 5101760

Status

Recruiting

Address

Saint Joseph's Regional Medical Center

Paterson 5102466, New Jersey 5101760, 07503

Site Contact

Site Public Contact

[email protected]

973-754-2207

Presbyterian Hospital, Albuquerque 5454711, New Mexico 5481136

Status

Recruiting

Address

Presbyterian Hospital

Albuquerque 5454711, New Mexico 5481136, 87106

Site Contact

Site Public Contact

[email protected]

505-559-6113

University of New Mexico Cancer Center, Albuquerque 5454711, New Mexico 5481136

Status

Recruiting

Address

University of New Mexico Cancer Center

Albuquerque 5454711, New Mexico 5481136, 87106

Site Contact

Site Public Contact

[email protected]

505-925-0348

Albany Medical Center, Albany 5106834, New York 5128638

Status

Recruiting

Address

Albany Medical Center

Albany 5106834, New York 5128638, 12208

Site Contact

Site Public Contact

518-262-5513

Maimonides Medical Center, Brooklyn 5110302, New York 5128638

Status

Recruiting

Address

Maimonides Medical Center

Brooklyn 5110302, New York 5128638, 11219

Site Contact

Site Public Contact

718-765-2500

Roswell Park Cancer Institute, Buffalo 5110629, New York 5128638

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo 5110629, New York 5128638, 14263

Site Contact

Site Public Contact

[email protected]

800-767-9355

NYU Langone Hospital - Long Island, Mineola 5127134, New York 5128638

Status

Recruiting

Address

NYU Langone Hospital - Long Island

Mineola 5127134, New York 5128638, 11501

Site Contact

Site Public Contact

[email protected]

212-263-4432

New Hyde Park 5128514, New York 5128638

Status

Recruiting

Address

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park 5128514, New York 5128638, 11040

Site Contact

Site Public Contact

718-470-3460

New York 5128581, New York 5128638

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York 5128581, New York 5128638, 10016

Site Contact

Site Public Contact

[email protected]

Mount Sinai Hospital, New York 5128581, New York 5128638

Status

Recruiting

Address

Mount Sinai Hospital

New York 5128581, New York 5128638, 10029

Site Contact

Site Public Contact

[email protected]

212-824-7309

New York 5128581, New York 5128638

Status

Recruiting

Address

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York 5128581, New York 5128638, 10032

Site Contact

Site Public Contact

[email protected]

212-342-5162

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

Site Contact

Site Public Contact

212-639-7592

NYP/Weill Cornell Medical Center, New York 5128581, New York 5128638

Status

Suspended

Address

NYP/Weill Cornell Medical Center

New York 5128581, New York 5128638, 10065

University of Rochester, Rochester 5134086, New York 5128638

Status

Recruiting

Address

University of Rochester

Rochester 5134086, New York 5128638, 14642

Site Contact

Site Public Contact

585-275-5830

Stony Brook University Medical Center, Stony Brook 5139865, New York 5128638

Status

Recruiting

Address

Stony Brook University Medical Center

Stony Brook 5139865, New York 5128638, 11794

Site Contact

Site Public Contact

800-862-2215

Syracuse 5140405, New York 5128638

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse 5140405, New York 5128638, 13210

Site Contact

Site Public Contact

315-464-5476

Montefiore Medical Center - Moses Campus, The Bronx 5110266, New York 5128638

Status

Recruiting

Address

Montefiore Medical Center - Moses Campus

The Bronx 5110266, New York 5128638, 10467

Site Contact

Site Public Contact

[email protected]

718-379-6866

New York Medical College, Valhalla 5142090, New York 5128638

Status

Recruiting

Address

New York Medical College

Valhalla 5142090, New York 5128638, 10595

Site Contact

Site Public Contact

914-594-3794

Mission Hospital, Asheville 4453066, North Carolina 4482348

Status

Recruiting

Address

Mission Hospital

Asheville 4453066, North Carolina 4482348, 28801

Site Contact

Site Public Contact

[email protected]

828-213-7055

Chapel Hill 4460162, North Carolina 4482348

Status

Recruiting

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill 4460162, North Carolina 4482348, 27599

Site Contact

Site Public Contact

[email protected]

877-668-0683

Charlotte 4460243, North Carolina 4482348

Status

Recruiting

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte 4460243, North Carolina 4482348, 28203

Site Contact

Site Public Contact

800-804-9376

Charlotte 4460243, North Carolina 4482348

Status

Recruiting

Address

Novant Health Presbyterian Medical Center

Charlotte 4460243, North Carolina 4482348, 28204

Site Contact

Site Public Contact

[email protected]

980-201-6360

Duke University Medical Center, Durham 4464368, North Carolina 4482348

Status

Recruiting

Address

Duke University Medical Center

Durham 4464368, North Carolina 4482348, 27710

Site Contact

Site Public Contact

888-275-3853

East Carolina University, Greenville 4469160, North Carolina 4482348

Status

Recruiting

Address

East Carolina University

Greenville 4469160, North Carolina 4482348, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

Wake Forest University Health Sciences, Winston-Salem 4499612, North Carolina 4482348

Status

Recruiting

Address

Wake Forest University Health Sciences

Winston-Salem 4499612, North Carolina 4482348, 27157

Site Contact

Site Public Contact

336-713-6771

Sanford Broadway Medical Center, Fargo 5059163, North Dakota 5690763

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo 5059163, North Dakota 5690763, 58122

Site Contact

Site Public Contact

[email protected]

701-323-5760

Akron 5145476, Ohio 5165418

Status

Recruiting

Address

Children's Hospital Medical Center of Akron

Akron 5145476, Ohio 5165418, 44308

Site Contact

Site Public Contact

330-543-3193

Cincinnati 4508722, Ohio 5165418

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati 4508722, Ohio 5165418, 45229

Site Contact

Site Public Contact

[email protected]

513-636-2799

Rainbow Babies and Childrens Hospital, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Rainbow Babies and Childrens Hospital

Cleveland 5150529, Ohio 5165418, 44106

Site Contact

Site Public Contact

216-844-5437

Cleveland Clinic Foundation, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland 5150529, Ohio 5165418, 44195

Site Contact

Site Public Contact

[email protected]

866-223-8100

Nationwide Children's Hospital, Columbus 4509177, Ohio 5165418

Status

Recruiting

Address

Nationwide Children's Hospital

Columbus 4509177, Ohio 5165418, 43205

Site Contact

Site Public Contact

[email protected]

614-722-6039

Dayton Children's Hospital, Dayton 4509884, Ohio 5165418

Status

Recruiting

Address

Dayton Children's Hospital

Dayton 4509884, Ohio 5165418, 45404

Site Contact

Site Public Contact

800-228-4055

Toledo 5174035, Ohio 5165418

Status

Recruiting

Address

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo 5174035, Ohio 5165418, 43606

Site Contact

Site Public Contact

[email protected]

419-824-1842

Oklahoma City 4544349, Oklahoma 4544379

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Tulsa 4553433, Oklahoma 4544379

Status

Recruiting

Address

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa 4553433, Oklahoma 4544379, 74136

Site Contact

Site Public Contact

918-494-2200

Legacy Emanuel Children's Hospital, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Legacy Emanuel Children's Hospital

Portland 5746545, Oregon 5744337, 97227

Site Contact

Site Public Contact

503-413-2560

Oregon Health and Science University, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Oregon Health and Science University

Portland 5746545, Oregon 5744337, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Lehigh Valley Hospital-Cedar Crest, Allentown 5178127, Pennsylvania 6254927

Status

Recruiting

Address

Lehigh Valley Hospital-Cedar Crest

Allentown 5178127, Pennsylvania 6254927, 18103

Site Contact

Site Public Contact

[email protected]

610-402-9543

Geisinger Medical Center, Danville 5186327, Pennsylvania 6254927

Status

Recruiting

Address

Geisinger Medical Center

Danville 5186327, Pennsylvania 6254927, 17822

Site Contact

Site Public Contact

[email protected]

570-271-5251

Penn State Children's Hospital, Hershey 5193342, Pennsylvania 6254927

Status

Recruiting

Address

Penn State Children's Hospital

Hershey 5193342, Pennsylvania 6254927, 17033

Site Contact

Site Public Contact

717-531-6012

Children's Hospital of Philadelphia, Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia 4560349, Pennsylvania 6254927, 19104

Site Contact

Site Public Contact

[email protected]

267-425-5544

Philadelphia 4560349, Pennsylvania 6254927

Status

Recruiting

Address

Saint Christopher's Hospital for Children

Philadelphia 4560349, Pennsylvania 6254927, 19134

Site Contact

Site Public Contact

215-427-8991

Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh 5206379, Pennsylvania 6254927, 15224

Site Contact

Site Public Contact

[email protected]

412-692-8570

Rhode Island Hospital, Providence 5224151, Rhode Island 5224323

Status

Recruiting

Address

Rhode Island Hospital

Providence 5224151, Rhode Island 5224323, 02903

Site Contact

Site Public Contact

401-444-1488

Medical University of South Carolina, Charleston 4574324, South Carolina 4597040

Status

Recruiting

Address

Medical University of South Carolina

Charleston 4574324, South Carolina 4597040, 29425

Site Contact

Site Public Contact

[email protected]

843-792-9321

Prisma Health Richland Hospital, Columbia 4575352, South Carolina 4597040

Status

Recruiting

Address

Prisma Health Richland Hospital

Columbia 4575352, South Carolina 4597040, 29203

Site Contact

Site Public Contact

[email protected]

864-522-4317

BI-LO Charities Children's Cancer Center, Greenville 4580543, South Carolina 4597040

Status

Recruiting

Address

BI-LO Charities Children's Cancer Center

Greenville 4580543, South Carolina 4597040, 29605

Site Contact

Site Public Contact

[email protected]

864-522-4317

Sanford USD Medical Center - Sioux Falls, Sioux Falls 5231851, South Dakota 5769223

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls 5231851, South Dakota 5769223, 57117-5134

Site Contact

Site Public Contact

[email protected]

605-312-3320

T C Thompson Children's Hospital, Chattanooga 4612862, Tennessee 4662168

Status

Recruiting

Address

T C Thompson Children's Hospital

Chattanooga 4612862, Tennessee 4662168, 37403

Site Contact

Site Public Contact

423-778-7289

East Tennessee Childrens Hospital, Knoxville 4634946, Tennessee 4662168

Status

Recruiting

Address

East Tennessee Childrens Hospital

Knoxville 4634946, Tennessee 4662168, 37916

Site Contact

Site Public Contact

865-541-8266

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

The Children's Hospital at TriStar Centennial

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

Site Public Contact

615-342-1919

Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Vanderbilt University/Ingram Cancer Center

Nashville 4644585, Tennessee 4662168, 37232

Site Contact

Site Public Contact

800-811-8480

Amarillo 5516233, Texas 4736286

Status

Recruiting

Address

Texas Tech University Health Sciences Center-Amarillo

Amarillo 5516233, Texas 4736286, 79106

Site Contact

Site Public Contact

806-354-5411

Austin 4671654, Texas 4736286

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin 4671654, Texas 4736286, 78723

Site Contact

Site Public Contact

[email protected]

512-628-1902

Driscoll Children's Hospital, Corpus Christi 4683416, Texas 4736286

Status

Recruiting

Address

Driscoll Children's Hospital

Corpus Christi 4683416, Texas 4736286, 78411

Site Contact

Site Public Contact

[email protected]

361-694-5311

Medical City Dallas Hospital, Dallas 4684888, Texas 4736286

Status

Recruiting

Address

Medical City Dallas Hospital

Dallas 4684888, Texas 4736286, 75230

Site Contact

Site Public Contact

972-566-5588

Dallas 4684888, Texas 4736286

Status

Recruiting

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas 4684888, Texas 4736286, 75390

Site Contact

Site Public Contact

[email protected]

214-648-7097

El Paso Children's Hospital, El Paso 5520993, Texas 4736286

Status

Recruiting

Address

El Paso Children's Hospital

El Paso 5520993, Texas 4736286, 79905

Site Contact

Site Public Contact

[email protected]

915-298-5444

Cook Children's Medical Center, Fort Worth 4691930, Texas 4736286

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth 4691930, Texas 4736286, 76104

Site Contact

Site Public Contact

[email protected]

682-885-2103

Houston 4699066, Texas 4736286

Status

Recruiting

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Site Public Contact

[email protected]

713-798-1354

M D Anderson Cancer Center, Houston 4699066, Texas 4736286

Status

Recruiting

Address

M D Anderson Cancer Center

Houston 4699066, Texas 4736286, 77030

Site Contact

Site Public Contact

[email protected]

877-632-6789

Covenant Children's Hospital, Lubbock 5525577, Texas 4736286

Status

Recruiting

Address

Covenant Children's Hospital

Lubbock 5525577, Texas 4736286, 79410

Site Contact

Site Public Contact

[email protected]

806-725-8657

UMC Cancer Center / UMC Health System, Lubbock 5525577, Texas 4736286

Status

Recruiting

Address

UMC Cancer Center / UMC Health System

Lubbock 5525577, Texas 4736286, 79415

Site Contact

Site Public Contact

806-775-8590

Vannie Cook Children's Clinic, McAllen 4709796, Texas 4736286

Status

Suspended

Address

Vannie Cook Children's Clinic

McAllen 4709796, Texas 4736286, 78503

Children's Hospital of San Antonio, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

Children's Hospital of San Antonio

San Antonio 4726206, Texas 4736286, 78207

Site Contact

Site Public Contact

[email protected]

210-704-2894

San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

Methodist Children's Hospital of South Texas

San Antonio 4726206, Texas 4736286, 78229

Site Contact

Site Public Contact

[email protected]

210-575-6240

San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio 4726206, Texas 4736286, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Scott and White Memorial Hospital, Temple 4735966, Texas 4736286

Status

Recruiting

Address

Scott and White Memorial Hospital

Temple 4735966, Texas 4736286, 76508

Site Contact

Site Public Contact

254-724-5407

Primary Children's Hospital, Salt Lake City 5780993, Utah 5549030

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City 5780993, Utah 5549030, 84113

Site Contact

Site Public Contact

801-585-5270

Burlington 5234372, Vermont 5242283

Status

Recruiting

Address

University of Vermont and State Agricultural College

Burlington 5234372, Vermont 5242283, 05405

Site Contact

Site Public Contact

[email protected]

802-656-8990

University of Virginia Cancer Center, Charlottesville 4752031, Virginia 6254928

Status

Recruiting

Address

University of Virginia Cancer Center

Charlottesville 4752031, Virginia 6254928, 22908

Site Contact

Site Public Contact

[email protected]

434-243-6303

Inova Fairfax Hospital, Falls Church 4758390, Virginia 6254928

Status

Recruiting

Address

Inova Fairfax Hospital

Falls Church 4758390, Virginia 6254928, 22042

Site Contact

Site Public Contact

[email protected]

703-208-6650

Norfolk 4776222, Virginia 6254928

Status

Recruiting

Address

Children's Hospital of The King's Daughters

Norfolk 4776222, Virginia 6254928, 23507

Site Contact

Site Public Contact

[email protected]

757-668-7243

Naval Medical Center - Portsmouth, Portsmouth 4779999, Virginia 6254928

Status

Recruiting

Address

Naval Medical Center - Portsmouth

Portsmouth 4779999, Virginia 6254928, 23708-2197

Site Contact

Site Public Contact

757-953-5939

VCU Massey Comprehensive Cancer Center, Richmond 4781708, Virginia 6254928

Status

Recruiting

Address

VCU Massey Comprehensive Cancer Center

Richmond 4781708, Virginia 6254928, 23298

Site Contact

Site Public Contact

[email protected]

804-628-6430

Carilion Children's, Roanoke 4782167, Virginia 6254928

Status

Recruiting

Address

Carilion Children's

Roanoke 4782167, Virginia 6254928, 24014

Site Contact

Site Public Contact

[email protected]

540-266-6238

Seattle Children's Hospital, Seattle 5809844, Washington 5815135

Status

Recruiting

Address

Seattle Children's Hospital

Seattle 5809844, Washington 5815135, 98105

Site Contact

Site Public Contact

866-987-2000

Spokane 5811696, Washington 5815135

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane 5811696, Washington 5815135, 99204

Site Contact

Site Public Contact

[email protected]

800-228-6618

Tacoma 5812944, Washington 5815135

Status

Recruiting

Address

Mary Bridge Children's Hospital and Health Center

Tacoma 5812944, Washington 5815135, 98405

Site Contact

Site Public Contact

[email protected]

253-403-1461

Madigan Army Medical Center, Tacoma 5812944, Washington 5815135

Status

Suspended

Address

Madigan Army Medical Center

Tacoma 5812944, Washington 5815135, 98431

Charleston 4801859, West Virginia 4826850

Status

Recruiting

Address

West Virginia University Charleston Division

Charleston 4801859, West Virginia 4826850, 25304

Site Contact

Site Public Contact

304-388-9944

Edwards Comprehensive Cancer Center, Huntington 4809537, West Virginia 4826850

Status

Suspended

Address

Edwards Comprehensive Cancer Center

Huntington 4809537, West Virginia 4826850, 25701

West Virginia University Healthcare, Morgantown 4815352, West Virginia 4826850

Status

Suspended

Address

West Virginia University Healthcare

Morgantown 4815352, West Virginia 4826850, 26506

Green Bay 5254962, Wisconsin 5279468

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center Green Bay

Green Bay 5254962, Wisconsin 5279468, 54301

Site Contact

Site Public Contact

[email protected]

920-433-8889

Madison 5261457, Wisconsin 5279468

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center - University Hospital

Madison 5261457, Wisconsin 5279468, 53792

Site Contact

Site Public Contact

[email protected]

800-622-8922

Marshfield Medical Center-Marshfield, Marshfield 5261969, Wisconsin 5279468

Status

Suspended

Address

Marshfield Medical Center-Marshfield

Marshfield 5261969, Wisconsin 5279468, 54449

Children's Hospital of Wisconsin, Milwaukee 5263045, Wisconsin 5279468

Status

Recruiting

Address

Children's Hospital of Wisconsin

Milwaukee 5263045, Wisconsin 5279468, 53226

Site Contact

Site Public Contact

[email protected]

414-955-4727

International Sites

John Hunter Children's Hospital, Hunter Regional Mail Centre, New South Wales 2155400, Australia

Status

Recruiting

Address

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales 2155400, 2310

Site Contact

Site Public Contact

(02) 4985 5180

The Children's Hospital at Westmead, Westmead 2143973, New South Wales 2155400, Australia

Status

Suspended

Address

The Children's Hospital at Westmead

Westmead 2143973, New South Wales 2155400, 2145

Queensland Children's Hospital, South Brisbane 2207259, Queensland 2152274, Australia

Status

Recruiting

Address

Queensland Children's Hospital

South Brisbane 2207259, Queensland 2152274, 4101

Site Contact

Site Public Contact

61 7 3068 1111

Women's and Children's Hospital-Adelaide, North Adelaide 8469169, South Australia 2061327, Australia

Status

Suspended

Address

Women's and Children's Hospital-Adelaide

North Adelaide 8469169, South Australia 2061327, 5006

Monash Medical Center-Clayton Campus, Clayton 2171400, Victoria 2145234, Australia

Status

Recruiting

Address

Monash Medical Center-Clayton Campus

Clayton 2171400, Victoria 2145234, 3168

Site Contact

Site Public Contact

(03) 9928 8111

Royal Children's Hospital, Parkville 2153770, Victoria 2145234, Australia

Status

Recruiting

Address

Royal Children's Hospital

Parkville 2153770, Victoria 2145234, 3052

Site Contact

Site Public Contact

[email protected]

61 3 9345 5656

Perth Children's Hospital, Perth 2063523, Western Australia 2058645, Australia

Status

Recruiting

Address

Perth Children's Hospital

Perth 2063523, Western Australia 2058645, 6009

Site Contact

Site Public Contact

[email protected]

Alberta Children's Hospital, Calgary 5913490, Alberta 5883102, Canada

Status

Recruiting

Address

Alberta Children's Hospital

Calgary 5913490, Alberta 5883102, T3B 6A8

Site Contact

Site Public Contact

[email protected]

403-220-6898

University of Alberta Hospital, Edmonton 5946768, Alberta 5883102, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton 5946768, Alberta 5883102, T6G 2B7

Site Contact

Site Public Contact

[email protected]

780-407-8798

British Columbia Children's Hospital, Vancouver 6173331, British Columbia 5909050, Canada

Status

Recruiting

Address

British Columbia Children's Hospital

Vancouver 6173331, British Columbia 5909050, V6H 3V4

Site Contact

Site Public Contact

604-875-2345 #6477

CancerCare Manitoba, Winnipeg 6183235, Manitoba 6065171, Canada

Status

Recruiting

Address

CancerCare Manitoba

Winnipeg 6183235, Manitoba 6065171, R3E 0V9

Site Contact

Site Public Contact

[email protected]

866-561-1026

Janeway Child Health Centre, St. John's 6324733, Newfoundland and Labrador 6354959, Canada

Status

Recruiting

Address

Janeway Child Health Centre

St. John's 6324733, Newfoundland and Labrador 6354959, A1B 3V6

Site Contact

Site Public Contact

[email protected]

709-777-8727

IWK Health Centre, Halifax 6324729, Nova Scotia 6091530, Canada

Status

Recruiting

Address

IWK Health Centre

Halifax 6324729, Nova Scotia 6091530, B3K 6R8

Site Contact

Site Public Contact

[email protected]

902-470-8520

Hamilton 5969782, Ontario 6093943, Canada

Status

Recruiting

Address

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton 5969782, Ontario 6093943, L8N 3Z5

Site Contact

Site Public Contact

905-521-2100

Kingston Health Sciences Centre, Kingston 5992500, Ontario 6093943, Canada

Status

Recruiting

Address

Kingston Health Sciences Centre

Kingston 5992500, Ontario 6093943, K7L 2V7

Site Contact

Site Public Contact

[email protected]

613-549-6666

Children's Hospital, London 6058560, Ontario 6093943, Canada

Status

Recruiting

Address

Children's Hospital

London 6058560, Ontario 6093943, N6A 5W9

Site Contact

Site Public Contact

519-685-8306

Children's Hospital of Eastern Ontario, Ottawa 6094817, Ontario 6093943, Canada

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa 6094817, Ontario 6093943, K1H 8L1

Site Contact

Site Public Contact

613-737-7600

Hospital for Sick Children, Toronto 6167865, Ontario 6093943, Canada

Status

Recruiting

Address

Hospital for Sick Children

Toronto 6167865, Ontario 6093943, M5G 1X8

Site Contact

Site Public Contact

[email protected]

416-813-7654

Montreal 6077243, Quebec 6115047, Canada

Status

Recruiting

Address

The Montreal Children's Hospital of the MUHC

Montreal 6077243, Quebec 6115047, H3H 1P3

Site Contact

Site Public Contact

[email protected]

514-412-4445

Sherbrooke 6146143, Quebec 6115047, Canada

Status

Recruiting

Address

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke 6146143, Quebec 6115047, J1H 5N4

Site Contact

Site Public Contact

[email protected]

819-820-6480

Jim Pattison Children's Hospital, Saskatoon 6141256, Saskatchewan 6141242, Canada

Status

Recruiting

Address

Jim Pattison Children's Hospital

Saskatoon 6141256, Saskatchewan 6141242, S7N 0W8

Site Contact

Site Public Contact

[email protected]

306-655-3544

Saskatoon Cancer Centre, Saskatoon 6141256, Saskatchewan 6141242, Canada

Status

Suspended

Address

Saskatoon Cancer Centre

Saskatoon 6141256, Saskatchewan 6141242, S7N 4H4

Québec 6325494, Canada

Status

Recruiting

Address

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec 6325494, , G1V 4G2

Site Contact

Site Public Contact

[email protected]

418-525-4444

Starship Children's Hospital, Grafton 6232401, Auckland 2193734, New Zealand

Status

Recruiting

Address

Starship Children's Hospital

Grafton 6232401, Auckland 2193734, 1145

Site Contact

Site Public Contact

0800 728 436

Christchurch Hospital, Christchurch 2192362, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch 2192362, , 8011

Site Contact

Site Public Contact

03 364 0640

HIMA San Pablo Oncologic Hospital, Caguas 4563008, Puerto Rico

Status

Active, not recruiting

Address

HIMA San Pablo Oncologic Hospital

Caguas 4563008, , 00726

University Pediatric Hospital, San Juan 4568127, Puerto Rico

Status

Recruiting

Address

University Pediatric Hospital

San Juan 4568127, , 00926

Site Contact

Site Public Contact

787-474-0333

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