Phase II Study of Rituximab as Upfront Window Therapy Before Chemotherapy in Pediatric Patients With Mature B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.
Basic Trial Information
|Phase II||Treatment||Closed||Under 19||Other||B-NHL-BFM-Rituximab|
EU-205119, NHL-BFM-RITUXIMAB, NCT00324779
- Determine the response rate in children and adolescents with B-cell non-Hodgkin's lymphoma (B-NHL) or B-cell acute lymphoblastic leukemia (B-ALL) treated with rituximab monotherapy as upfront window therapy before chemotherapy.
- Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen.
- Investigate the rituximab response in patients treated with this regimen.
- Determine the toxicity profile of rituximab in these patients.
- Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen.
- Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia
- CD20 positive disease
- At least 2 weeks since prior corticosteroids
- No prior radiotherapy
- No prior or concurrent chemotherapy
- No concurrent treatment in another investigational trial
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Adequate general condition with sufficient organ function (hepatic, renal, and cardiac)
- No known disease that would preclude protocol therapy with rituximab
- No known allergies against proteins
- No acute or previous hepatitis B infection
A total of 79 patients will be accrued for this study.
Effect of rituximab on different histological subtypes
Pharmacokinetics and pharmacodynamics
This is a multicenter study.
Patients receive rituximab IV on day 1.
Trial Contact Information
Trial Lead Organizations
|Official Title||Multicenter Therapy Study for Children with Mature B-NHL or B-ALL with a Rituximab - Window Before Chemotherapy|
|Trial Start Date||2004-03-01|
|Registered in ClinicalTrials.gov||NCT00324779|
|Date Submitted to PDQ||2006-01-06|
|Information Last Verified||2007-11-19|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.