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.

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

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital of Alabama, Birmingham, Alabama

Status

Recruiting

Address

Children's Hospital of Alabama

Birmingham, Alabama, 35233

Site Contact

Site Public Contact

[email protected]

205-638-9285

USA Health Strada Patient Care Center, Mobile, Alabama

Status

Recruiting

Address

USA Health Strada Patient Care Center

Mobile, Alabama, 36604

Site Contact

Site Public Contact

800-388-8721

Providence Alaska Medical Center, Anchorage, Alaska

Status

Recruiting

Address

Providence Alaska Medical Center

Anchorage, Alaska, 99508

Site Contact

Site Public Contact

[email protected]

907-212-6871

Banner Children's at Desert, Mesa, Arizona

Status

Recruiting

Address

Banner Children's at Desert

Mesa, Arizona, 85202

Site Contact

Site Public Contact

480-412-3100

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Suspended

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Tucson, Arizona

Status

Suspended

Address

Banner University Medical Center - Tucson

Tucson, Arizona, 85719

Arkansas Children's Hospital, Little Rock, Arkansas

Status

Recruiting

Address

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

Site Contact

Site Public Contact

501-364-7373

Kaiser Permanente Downey Medical Center, Downey, California

Status

Recruiting

Address

Kaiser Permanente Downey Medical Center

Downey, California, 90242

Site Contact

Site Public Contact

626-564-3455

City of Hope Comprehensive Cancer Center, Duarte, California

Status

Recruiting

Address

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Site Contact

Site Public Contact

[email protected]

800-826-4673

Loma Linda University Medical Center, Loma Linda, California

Status

Recruiting

Address

Loma Linda University Medical Center

Loma Linda, California, 92354

Site Contact

Site Public Contact

909-558-4050

Long Beach, California

Status

Recruiting

Address

Miller Children's and Women's Hospital Long Beach

Long Beach, California, 90806

Site Contact

Site Public Contact

562-933-5600

Children's Hospital Los Angeles, Los Angeles, California

Status

Recruiting

Address

Children's Hospital Los Angeles

Los Angeles, California, 90027

Site Contact

Site Public Contact

323-361-4110

Cedars Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Site Public Contact

310-423-8965

Mattel Children's Hospital UCLA, Los Angeles, California

Status

Suspended

Address

Mattel Children's Hospital UCLA

Los Angeles, California, 90095

Valley Children's Hospital, Madera, California

Status

Recruiting

Address

Valley Children's Hospital

Madera, California, 93636

Site Contact

Site Public Contact

[email protected]

559-353-3000

UCSF Benioff Children's Hospital Oakland, Oakland, California

Status

Recruiting

Address

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

Site Contact

Site Public Contact

[email protected]

510-428-3264

Kaiser Permanente-Oakland, Oakland, California

Status

Recruiting

Address

Kaiser Permanente-Oakland

Oakland, California, 94611

Site Contact

Site Public Contact

[email protected]

877-642-4691

Children's Hospital of Orange County, Orange, California

Status

Recruiting

Address

Children's Hospital of Orange County

Orange, California, 92868

Site Contact

Site Public Contact

[email protected]

714-509-8646

Palo Alto, California

Status

Recruiting

Address

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

Site Contact

Site Public Contact

[email protected]

800-694-0012

Sutter Medical Center Sacramento, Sacramento, California

Status

Suspended

Address

Sutter Medical Center Sacramento

Sacramento, California, 95816

Sacramento, California

Status

Recruiting

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Site Contact

Site Public Contact

916-734-3089

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

Status

Recruiting

Address

Rady Children's Hospital - San Diego

San Diego, California, 92123

Site Contact

Site Public Contact

858-966-5934

Naval Medical Center -San Diego, San Diego, California

Status

Recruiting

Address

Naval Medical Center -San Diego

San Diego, California, 92134

Site Contact

Site Public Contact

619-532-8712

UCSF Medical Center-Mission Bay, San Francisco, California

Status

Recruiting

Address

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

Site Contact

Site Public Contact

[email protected]

877-827-3222

Santa Barbara Cottage Hospital, Santa Barbara, California

Status

Recruiting

Address

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102

Site Contact

Site Public Contact

805-682-7300

Torrance, California

Status

Active, not recruiting

Address

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Site Contact

Site Public Contact

[email protected]

303-764-5056

Denver, Colorado

Status

Suspended

Address

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

Denver, Colorado, 80218

Connecticut Children's Medical Center, Hartford, Connecticut

Status

Recruiting

Address

Connecticut Children's Medical Center

Hartford, Connecticut, 06106

Site Contact

Site Public Contact

860-545-9981

Yale University, New Haven, Connecticut

Status

Recruiting

Address

Yale University

New Haven, Connecticut, 06520

Site Contact

Site Public Contact

[email protected]

203-785-5702

Alfred I duPont Hospital for Children, Wilmington, Delaware

Status

Recruiting

Address

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

Site Contact

Site Public Contact

[email protected]

302-651-5572

MedStar Georgetown University Hospital, Washington, District of Columbia

Status

Suspended

Address

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

Children's National Medical Center, Washington, District of Columbia

Status

Recruiting

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Site Contact

Site Public Contact

[email protected]

202-476-2800

Broward Health Medical Center, Fort Lauderdale, Florida

Status

Recruiting

Address

Broward Health Medical Center

Fort Lauderdale, Florida, 33316

Site Contact

Site Public Contact

[email protected]

302-651-5572

Fort Myers, Florida

Status

Suspended

Address

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908

Gainesville, Florida

Status

Recruiting

Address

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

Site Contact

Site Public Contact

[email protected]

352-273-8010

Hollywood, Florida

Status

Recruiting

Address

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

Site Contact

Site Public Contact

[email protected]

954-265-1847

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

Site Contact

Site Public Contact

[email protected]

302-651-5572

Palms West Radiation Therapy, Loxahatchee Groves, Florida

Status

Active, not recruiting

Address

Palms West Radiation Therapy

Loxahatchee Groves, Florida, 33470

Miami, Florida

Status

Suspended

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Nicklaus Children's Hospital, Miami, Florida

Status

Suspended

Address

Nicklaus Children's Hospital

Miami, Florida, 33155

Miami Cancer Institute, Miami, Florida

Status

Suspended

Address

Miami Cancer Institute

Miami, Florida, 33176

AdventHealth Orlando, Orlando, Florida

Status

Recruiting

Address

AdventHealth Orlando

Orlando, Florida, 32803

Site Contact

Site Public Contact

[email protected]

407-303-2090

Arnold Palmer Hospital for Children, Orlando, Florida

Status

Recruiting

Address

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

Site Contact

Site Public Contact

[email protected]

321-841-5357

Nemours Children's Hospital, Orlando, Florida

Status

Recruiting

Address

Nemours Children's Hospital

Orlando, Florida, 32827

Site Contact

Site Public Contact

[email protected]

302-651-5572

Sacred Heart Hospital, Pensacola, Florida

Status

Recruiting

Address

Sacred Heart Hospital

Pensacola, Florida, 32504

Site Contact

Site Public Contact

[email protected]

850-416-4611

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida

Status

Recruiting

Address

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

Site Contact

Site Public Contact

[email protected]

727-767-4784

Tampa General Hospital, Tampa, Florida

Status

Recruiting

Address

Tampa General Hospital

Tampa, Florida, 33606

Site Contact

Site Public Contact

[email protected]

813-844-7829

Tampa, Florida

Status

Recruiting

Address

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

Tampa, Florida, 33607

Site Contact

Site Public Contact

[email protected]

813-357-0849

Saint Mary's Hospital, West Palm Beach, Florida

Status

Recruiting

Address

Saint Mary's Hospital

West Palm Beach, Florida, 33407

Site Contact

Site Public Contact

561-881-2815

Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, 30322

Site Contact

Site Public Contact

[email protected]

404-785-2025

Augusta University Medical Center, Augusta, Georgia

Status

Recruiting

Address

Augusta University Medical Center

Augusta, Georgia, 30912

Site Contact

Site Public Contact

[email protected]

706-721-2388

Medical Center of Central Georgia, Macon, Georgia

Status

Recruiting

Address

Medical Center of Central Georgia

Macon, Georgia, 31201

Site Contact

Site Public Contact

[email protected]

478-633-2152

Savannah, Georgia

Status

Recruiting

Address

Memorial Health University Medical Center

Savannah, Georgia, 31404

Site Contact

Site Public Contact

[email protected]

912-350-7887

Honolulu, Hawaii

Status

Suspended

Address

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826

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

Status

Recruiting

Address

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Site Contact

Site Public Contact

[email protected]

208-381-2774

Lurie Children's Hospital-Chicago, Chicago, Illinois

Status

Recruiting

Address

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

Site Contact

Site Public Contact

773-880-4562

University of Illinois, Chicago, Illinois

Status

Suspended

Address

University of Illinois

Chicago, Illinois, 60612

Chicago, Illinois

Status

Recruiting

Address

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Site Contact

Site Public Contact

[email protected]

773-702-8222

Loyola University Medical Center, Maywood, Illinois

Status

Suspended

Address

Loyola University Medical Center

Maywood, Illinois, 60153

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

Status

Suspended

Address

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois, 60453

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

Status

Suspended

Address

Advocate Children's Hospital-Park Ridge

Park Ridge, Illinois, 60068

Saint Jude Midwest Affiliate, Peoria, Illinois

Status

Recruiting

Address

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637

Site Contact

Site Public Contact

888-226-4343

Springfield, Illinois

Status

Suspended

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Winfield, Illinois

Status

Recruiting

Address

Northwestern Medicine Central DuPage Hospital

Winfield, Illinois, 60190

Site Contact

Site Public Contact

[email protected]

630-315-1918

Riley Hospital for Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Site Contact

Site Public Contact

800-248-1199

Indianapolis, Indiana

Status

Recruiting

Address

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260

Site Contact

Site Public Contact

[email protected]

317-338-2194

Blank Children's Hospital, Des Moines, Iowa

Status

Recruiting

Address

Blank Children's Hospital

Des Moines, Iowa, 50309

Site Contact

Site Public Contact

[email protected]

515-241-8912

Iowa City, Iowa

Status

Recruiting

Address

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242

Site Contact

Site Public Contact

800-237-1225

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536

Site Contact

Site Public Contact

859-257-3379

Norton Children's Hospital, Louisville, Kentucky

Status

Recruiting

Address

Norton Children's Hospital

Louisville, Kentucky, 40202

Site Contact

Site Public Contact

[email protected]

502-629-5500

Children's Hospital New Orleans, New Orleans, Louisiana

Status

Recruiting

Address

Children's Hospital New Orleans

New Orleans, Louisiana, 70118

Site Contact

Site Public Contact

[email protected]

Ochsner Medical Center Jefferson, New Orleans, Louisiana

Status

Recruiting

Address

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Site Contact

Site Public Contact

[email protected]

504-842-8084

Eastern Maine Medical Center, Bangor, Maine

Status

Recruiting

Address

Eastern Maine Medical Center

Bangor, Maine, 04401

Site Contact

Site Public Contact

207-973-4274

Maine Children's Cancer Program, Scarborough, Maine

Status

Recruiting

Address

Maine Children's Cancer Program

Scarborough, Maine, 04074

Site Contact

Site Public Contact

[email protected]

207-396-7581

Baltimore, Maryland

Status

Suspended

Address

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Sinai Hospital of Baltimore, Baltimore, Maryland

Status

Recruiting

Address

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215

Site Contact

Site Public Contact

[email protected]

410-601-6120

Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

Site Contact

Site Public Contact

[email protected]

410-955-8804

Bethesda, Maryland

Status

Suspended

Address

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600

Tufts Children's Hospital, Boston, Massachusetts

Status

Active, not recruiting

Address

Tufts Children's Hospital

Boston, Massachusetts, 02111

Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Site Contact

Site Public Contact

877-726-5130

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Suspended

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Baystate Medical Center, Springfield, Massachusetts

Status

Suspended

Address

Baystate Medical Center

Springfield, Massachusetts, 01199

Worcester, Massachusetts

Status

Recruiting

Address

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655

Site Contact

Site Public Contact

[email protected]

508-856-3216

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

Status

Recruiting

Address

C S Mott Children's Hospital

Ann Arbor, Michigan, 48109

Site Contact

Site Public Contact

800-865-1125

Children's Hospital of Michigan, Detroit, Michigan

Status

Recruiting

Address

Children's Hospital of Michigan

Detroit, Michigan, 48201

Site Contact

Site Public Contact

[email protected]

Ascension Saint John Hospital, Detroit, Michigan

Status

Active, not recruiting

Address

Ascension Saint John Hospital

Detroit, Michigan, 48236

East Lansing, Michigan

Status

Recruiting

Address

Michigan State University Clinical Center

East Lansing, Michigan, 48824

Site Contact

Site Public Contact

517-975-9547

Grand Rapids, Michigan

Status

Recruiting

Address

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503

Site Contact

Site Public Contact

[email protected]

616-267-1925

Bronson Methodist Hospital, Kalamazoo, Michigan

Status

Recruiting

Address

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

[email protected]

616-391-1230

Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Children's Hospital-Royal Oak

Royal Oak, Michigan, 48073

Site Contact

Site Public Contact

248-551-7695

Minneapolis, Minnesota

Status

Recruiting

Address

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, 55404

Site Contact

Site Public Contact

[email protected]

612-813-5913

Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455

Site Contact

Site Public Contact

612-624-2620

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

855-776-0015

University of Mississippi Medical Center, Jackson, Mississippi

Status

Recruiting

Address

University of Mississippi Medical Center

Jackson, Mississippi, 39216

Site Contact

Site Public Contact

601-815-6700

Columbia Regional, Columbia, Missouri

Status

Suspended

Address

Columbia Regional

Columbia, Missouri, 65201

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

Status

Recruiting

Address

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

Site Contact

Site Public Contact

[email protected]

816-302-6808

Saint Louis, Missouri

Status

Recruiting

Address

Cardinal Glennon Children's Medical Center

Saint Louis, Missouri, 63104

Site Contact

Site Public Contact

314-268-4000

Washington University School of Medicine, Saint Louis, Missouri

Status

Suspended

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Mercy Hospital Saint Louis, Saint Louis, Missouri

Status

Recruiting

Address

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

Site Contact

Site Public Contact

314-251-7066

Omaha, Nebraska

Status

Recruiting

Address

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

Site Contact

Site Public Contact

402-955-3949

University of Nebraska Medical Center, Omaha, Nebraska

Status

Recruiting

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Site Contact

Site Public Contact

[email protected]

402-559-6941

Las Vegas, Nevada

Status

Suspended

Address

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Sunrise Hospital and Medical Center, Las Vegas, Nevada

Status

Suspended

Address

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

Las Vegas, Nevada

Status

Recruiting

Address

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Site Contact

Site Public Contact

[email protected]

702-384-0013

Summerlin Hospital Medical Center, Las Vegas, Nevada

Status

Recruiting

Address

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

Site Contact

Site Public Contact

[email protected]

702-384-0013

Renown Regional Medical Center, Reno, Nevada

Status

Recruiting

Address

Renown Regional Medical Center

Reno, Nevada, 89502

Site Contact

Site Public Contact

[email protected]

702-384-0013

Lebanon, New Hampshire

Status

Suspended

Address

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Site Contact

Site Public Contact

201-996-2879

Morristown Medical Center, Morristown, New Jersey

Status

Recruiting

Address

Morristown Medical Center

Morristown, New Jersey, 07960

Site Contact

Site Public Contact

973-971-5900

Jersey Shore Medical Center, Neptune, New Jersey

Status

Recruiting

Address

Jersey Shore Medical Center

Neptune, New Jersey, 07753

Site Contact

Site Public Contact

732-776-4240

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

Status

Recruiting

Address

Saint Peter's University Hospital

New Brunswick, New Jersey, 08901

Site Contact

Site Public Contact

[email protected]

732-745-8600 #6163

New Brunswick, New Jersey

Status

Recruiting

Address

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

New Brunswick, New Jersey, 08903

Site Contact

Site Public Contact

732-235-8675

Newark Beth Israel Medical Center, Newark, New Jersey

Status

Suspended

Address

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

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

Status

Recruiting

Address

Saint Joseph's Regional Medical Center

Paterson, New Jersey, 07503

Site Contact

Site Public Contact

[email protected]

973-754-2207

University of New Mexico Cancer Center, Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102

Site Contact

Site Public Contact

[email protected]

505-925-0348

Presbyterian Hospital, Albuquerque, New Mexico

Status

Recruiting

Address

Presbyterian Hospital

Albuquerque, New Mexico, 87106

Site Contact

Site Public Contact

[email protected]

505-559-6113

Albany Medical Center, Albany, New York

Status

Suspended

Address

Albany Medical Center

Albany, New York, 12208

Montefiore Medical Center - Moses Campus, Bronx, New York

Status

Suspended

Address

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

Maimonides Medical Center, Brooklyn, New York

Status

Recruiting

Address

Maimonides Medical Center

Brooklyn, New York, 11219

Site Contact

Site Public Contact

718-765-2500

Roswell Park Cancer Institute, Buffalo, New York

Status

Recruiting

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Site Contact

Site Public Contact

[email protected]

800-767-9355

NYU Winthrop Hospital, Mineola, New York

Status

Recruiting

Address

NYU Winthrop Hospital

Mineola, New York, 11501

Site Contact

Site Public Contact

[email protected]

212-263-4432

New Hyde Park, New York

Status

Recruiting

Address

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

New Hyde Park, New York, 11040

Site Contact

Site Public Contact

718-470-3460

New York, New York

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

Site Contact

Site Public Contact

[email protected]

Mount Sinai Hospital, New York, New York

Status

Recruiting

Address

Mount Sinai Hospital

New York, New York, 10029

Site Contact

Site Public Contact

[email protected]

212-824-7309

New York, New York

Status

Recruiting

Address

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

New York, New York, 10032

Site Contact

Site Public Contact

[email protected]

212-342-5162

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Site Public Contact

212-639-7592

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

Status

Suspended

Address

NYP/Weill Cornell Medical Center

New York, New York, 10065

University of Rochester, Rochester, New York

Status

Recruiting

Address

University of Rochester

Rochester, New York, 14642

Site Contact

Site Public Contact

585-275-5830

Stony Brook University Medical Center, Stony Brook, New York

Status

Suspended

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

Syracuse, New York

Status

Recruiting

Address

State University of New York Upstate Medical University

Syracuse, New York, 13210

Site Contact

Site Public Contact

315-464-5476

New York Medical College, Valhalla, New York

Status

Recruiting

Address

New York Medical College

Valhalla, New York, 10595

Site Contact

Site Public Contact

914-594-3794

Mission Hospital, Asheville, North Carolina

Status

Suspended

Address

Mission Hospital

Asheville, North Carolina, 28801

Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Site Contact

Site Public Contact

[email protected]

877-668-0683

Charlotte, North Carolina

Status

Recruiting

Address

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, 28203

Site Contact

Site Public Contact

800-804-9376

Charlotte, North Carolina

Status

Suspended

Address

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Site Public Contact

888-275-3853

East Carolina University, Greenville, North Carolina

Status

Recruiting

Address

East Carolina University

Greenville, North Carolina, 27834

Site Contact

Site Public Contact

[email protected]

252-744-1015

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

Status

Suspended

Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Sanford Broadway Medical Center, Fargo, North Dakota

Status

Recruiting

Address

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

Site Contact

Site Public Contact

[email protected]

701-323-5760

Akron, Ohio

Status

Recruiting

Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Site Contact

Site Public Contact

330-543-3193

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Site Public Contact

[email protected]

513-636-2799

Rainbow Babies and Childrens Hospital, Cleveland, Ohio

Status

Recruiting

Address

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

Site Contact

Site Public Contact

216-844-5437

Cleveland Clinic Foundation, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

Site Contact

Site Public Contact

[email protected]

866-223-8100

Nationwide Children's Hospital, Columbus, Ohio

Status

Suspended

Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Dayton Children's Hospital, Dayton, Ohio

Status

Recruiting

Address

Dayton Children's Hospital

Dayton, Ohio, 45404

Site Contact

Site Public Contact

800-228-4055

Toledo, Ohio

Status

Suspended

Address

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital

Toledo, Ohio, 43606

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

[email protected]

405-271-8777

Tulsa, Oklahoma

Status

Suspended

Address

Natalie Warren Bryant Cancer Center at Saint Francis

Tulsa, Oklahoma, 74136

Legacy Emanuel Children's Hospital, Portland, Oregon

Status

Recruiting

Address

Legacy Emanuel Children's Hospital

Portland, Oregon, 97227

Site Contact

Site Public Contact

503-413-2560

Oregon Health and Science University, Portland, Oregon

Status

Recruiting

Address

Oregon Health and Science University

Portland, Oregon, 97239

Site Contact

Site Public Contact

[email protected]

503-494-1080

Lehigh Valley Hospital-Cedar Crest, Allentown, Pennsylvania

Status

Suspended

Address

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

Geisinger Medical Center, Danville, Pennsylvania

Status

Suspended

Address

Geisinger Medical Center

Danville, Pennsylvania, 17822

Penn State Children's Hospital, Hershey, Pennsylvania

Status

Recruiting

Address

Penn State Children's Hospital

Hershey, Pennsylvania, 17033

Site Contact

Site Public Contact

717-531-6012

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Site Contact

Site Public Contact

[email protected]

267-425-5544

Philadelphia, Pennsylvania

Status

Recruiting

Address

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134

Site Contact

Site Public Contact

215-427-8991

Pittsburgh, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

Site Contact

Site Public Contact

[email protected]

412-692-8570

Rhode Island Hospital, Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital

Providence, Rhode Island, 02903

Site Contact

Site Public Contact

401-444-1488

Medical University of South Carolina, Charleston, South Carolina

Status

Suspended

Address

Medical University of South Carolina

Charleston, South Carolina, 29425

Prisma Health Richland Hospital, Columbia, South Carolina

Status

Recruiting

Address

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

Site Contact

Site Public Contact

864-241-6251

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

Status

Recruiting

Address

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, 29605

Site Contact

Site Public Contact

864-241-6251

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

Status

Recruiting

Address

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

Site Contact

Site Public Contact

[email protected]

605-312-3320

T C Thompson Children's Hospital, Chattanooga, Tennessee

Status

Suspended

Address

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403

East Tennessee Childrens Hospital, Knoxville, Tennessee

Status

Recruiting

Address

East Tennessee Childrens Hospital

Knoxville, Tennessee, 37916

Site Contact

Site Public Contact

865-541-8266

Nashville, Tennessee

Status

Recruiting

Address

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, 37203

Site Contact

Site Public Contact

615-342-1919

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Site Contact

Site Public Contact

800-811-8480

Amarillo, Texas

Status

Recruiting

Address

Texas Tech University Health Sciences Center-Amarillo

Amarillo, Texas, 79106

Site Contact

Site Public Contact

806-354-5411

Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

Site Contact

Site Public Contact

[email protected]

512-628-1902

Driscoll Children's Hospital, Corpus Christi, Texas

Status

Recruiting

Address

Driscoll Children's Hospital

Corpus Christi, Texas, 78411

Site Contact

Site Public Contact

[email protected]

361-694-5311

Medical City Dallas Hospital, Dallas, Texas

Status

Recruiting

Address

Medical City Dallas Hospital

Dallas, Texas, 75230

Site Contact

Site Public Contact

972-566-5588

Dallas, Texas

Status

Suspended

Address

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

El Paso Children's Hospital, El Paso, Texas

Status

Recruiting

Address

El Paso Children's Hospital

El Paso, Texas, 79905

Site Contact

Site Public Contact

[email protected]

915-298-5444

Cook Children's Medical Center, Fort Worth, Texas

Status

Recruiting

Address

Cook Children's Medical Center

Fort Worth, Texas, 76104

Site Contact

Site Public Contact

[email protected]

682-885-2103

Houston, Texas

Status

Recruiting

Address

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

713-798-1354

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

[email protected]

877-632-6789

Covenant Children's Hospital, Lubbock, Texas

Status

Recruiting

Address

Covenant Children's Hospital

Lubbock, Texas, 79410

Site Contact

Site Public Contact

[email protected]

806-725-8657

UMC Cancer Center / UMC Health System, Lubbock, Texas

Status

Recruiting

Address

UMC Cancer Center / UMC Health System

Lubbock, Texas, 79415

Site Contact

Site Public Contact

806-775-8590

Vannie Cook Children's Clinic, McAllen, Texas

Status

Recruiting

Address

Vannie Cook Children's Clinic

McAllen, Texas, 78503

Site Contact

Site Public Contact

[email protected]

832-828-1727

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

Status

Recruiting

Address

Children's Hospital of San Antonio

San Antonio, Texas, 78207

Site Contact

Site Public Contact

[email protected]

210-704-2894

San Antonio, Texas

Status

Recruiting

Address

Methodist Children's Hospital of South Texas

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-575-6240

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

Site Contact

Site Public Contact

[email protected]

210-450-3800

Scott and White Memorial Hospital, Temple, Texas

Status

Recruiting

Address

Scott and White Memorial Hospital

Temple, Texas, 76508

Site Contact

Site Public Contact

254-724-5407

Primary Children's Hospital, Salt Lake City, Utah

Status

Recruiting

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Site Contact

Site Public Contact

801-585-5270

Burlington, Vermont

Status

Recruiting

Address

University of Vermont and State Agricultural College

Burlington, Vermont, 05405

Site Contact

Site Public Contact

[email protected]

802-656-8990

University of Virginia Cancer Center, Charlottesville, Virginia

Status

Suspended

Address

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

Inova Fairfax Hospital, Falls Church, Virginia

Status

Recruiting

Address

Inova Fairfax Hospital

Falls Church, Virginia, 22042

Site Contact

Site Public Contact

[email protected]

703-208-6650

Norfolk, Virginia

Status

Recruiting

Address

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

Site Contact

Site Public Contact

[email protected]

757-668-7243

Naval Medical Center - Portsmouth, Portsmouth, Virginia

Status

Recruiting

Address

Naval Medical Center - Portsmouth

Portsmouth, Virginia, 23708-2197

Site Contact

Site Public Contact

757-953-5939

Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Site Public Contact

[email protected]

Carilion Children's, Roanoke, Virginia

Status

Recruiting

Address

Carilion Children's

Roanoke, Virginia, 24014

Site Contact

Site Public Contact

[email protected]

540-266-6238

Seattle Children's Hospital, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital

Seattle, Washington, 98105

Site Contact

Site Public Contact

866-987-2000

Spokane, Washington

Status

Recruiting

Address

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204

Site Contact

Site Public Contact

[email protected]

800-228-6618

Tacoma, Washington

Status

Recruiting

Address

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

Site Contact

Site Public Contact

[email protected]

253-403-1461

Madigan Army Medical Center, Tacoma, Washington

Status

Suspended

Address

Madigan Army Medical Center

Tacoma, Washington, 98431

Charleston, West Virginia

Status

Suspended

Address

West Virginia University Charleston Division

Charleston, West Virginia, 25304

Edwards Comprehensive Cancer Center, Huntington, West Virginia

Status

Suspended

Address

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701

West Virginia University Healthcare, Morgantown, West Virginia

Status

Suspended

Address

West Virginia University Healthcare

Morgantown, West Virginia, 26506

Green Bay, Wisconsin

Status

Suspended

Address

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

Site Contact

Site Public Contact

[email protected]

800-622-8922

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin

Status

Recruiting

Address

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Site Contact

Site Public Contact

[email protected]

800-782-8581

Children's Hospital of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 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, Australia

Status

Recruiting

Address

John Hunter Children's Hospital

Hunter Regional Mail Centre, New South Wales, 2310

Site Contact

Site Public Contact

(02) 4985 5180

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

Status

Suspended

Address

The Children's Hospital at Westmead

Westmead, New South Wales, 2145

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

Status

Recruiting

Address

Queensland Children's Hospital

South Brisbane, Queensland, 4101

Site Contact

Site Public Contact

61 7 3068 1111

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

Status

Suspended

Address

Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, 5006

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

Status

Recruiting

Address

Monash Medical Center-Clayton Campus

Clayton, Victoria, 3168

Site Contact

Site Public Contact

(03) 9928 8111

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

Status

Recruiting

Address

Perth Children's Hospital

Perth, Western Australia, 6009

Site Contact

Site Public Contact

[email protected]

Alberta Children's Hospital, Calgary, Alberta, Canada

Status

Suspended

Address

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7

Site Contact

Site Public Contact

[email protected]

780-407-8798

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

Status

Suspended

Address

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Recruiting

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9

Site Contact

Site Public Contact

[email protected]

866-561-1026

Janeway Child Health Centre, Saint John's, Newfoundland and Labrador, Canada

Status

Suspended

Address

Janeway Child Health Centre

Saint John's, Newfoundland and Labrador, A1B 3V6

IWK Health Centre, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8

Site Contact

Site Public Contact

[email protected]

902-470-8520

Hamilton, Ontario, Canada

Status

Recruiting

Address

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5

Site Contact

Site Public Contact

905-521-2100

Kingston Health Sciences Centre, Kingston, Ontario, Canada

Status

Recruiting

Address

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7

Site Contact

Site Public Contact

[email protected]

613-549-6666

Children's Hospital, London, Ontario, Canada

Status

Suspended

Address

Children's Hospital

London, Ontario, N6A 5W9

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

Status

Recruiting

Address

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1

Site Contact

Site Public Contact

613-737-7600

Hospital for Sick Children, Toronto, Ontario, Canada

Status

Suspended

Address

Hospital for Sick Children

Toronto, Ontario, M5G 1X8

Montreal, Quebec, Canada

Status

Suspended

Address

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, H3H 1P3

Sherbrooke, Quebec, Canada

Status

Suspended

Address

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, J1H 5N4

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

Status

Suspended

Address

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Status

Suspended

Address

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4

Quebec, Canada

Status

Suspended

Address

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

Quebec, , G1V 4G2

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

Status

Recruiting

Address

Starship Children's Hospital

Grafton, Auckland, 1145

Site Contact

Site Public Contact

0800 728 436

Christchurch Hospital, Christchurch, New Zealand

Status

Recruiting

Address

Christchurch Hospital

Christchurch, , 8011

Site Contact

Site Public Contact

03 364 0640

HIMA San Pablo Oncologic Hospital, Caguas, Puerto Rico

Status

Suspended

Address

HIMA San Pablo Oncologic Hospital

Caguas, , 00726

University Pediatric Hospital, San Juan, Puerto Rico

Status

Suspended

Address

University Pediatric Hospital

San Juan, , 00926

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