Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy

Study Purpose

This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.

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	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

- Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).

Exclusion criteria:

- Involved sites other than the brain, meninges, CSF, or the eyes.

- Age less than 18 years or greater than 75 years.

- Inadequate bone marrow capacity (defined as neutrophils<1.5 ×10^9/L, platelets <100 ×10^9/L, and hemoglobin level< 8 g/dL).

- Known cause of immunosuppression (ie, HIV type I infection).

- Any previous malignancy.

- Creatinine clearance below 60 mL/min.

- Heart insufficiency (NYHA IIIB or IV).

- Uncontrolled infection.

- Noncompensated active pulmonary or liver disease.

- Previously treated for PCNSL, except by corticosteroids.

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.	NCT02657785
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 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Navy General Hospital, Beijing
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Liren Qian, M.D.
Principal Investigator Affiliation	Navy General Hospital, Beijing
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Primary Central Nervous System Lymphoma

Additional Details

The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity in primary central nervous system lymphoma (PCNSL) after systemic and intrathecal immunochemotherapy with deferred radiotherapy.

Arms & Interventions

Arms

Experimental: R-IDARAM plus intrathecal chemotherapy

Patients will be treated with systemic R-IDARAM plus intrathecal immunochemotherapy

Interventions

Drug: - R-IDARAM plus intrathecal chemotherapy

R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.

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.

International Sites

Navy General Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Navy General Hospital

Beijing, Beijing, 100048

Site Contact

Liren Qian, M.D.

qlr2007@126.com

+861066957676

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