Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00324779|
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : September 25, 2015
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving rituximab before chemotherapy may be an effective treatment for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.
PURPOSE: This phase II trial is studying how well rituximab works in treating young patients who are planning to receive chemotherapy for B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Biological: rituximab||Phase 2|
- 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.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on day 1.
PROJECTED ACCRUAL: A total of 79 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||79 participants|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||April 2011|
- Response rate
- Effect of rituximab on different histological subtypes
- Rituximab response
- Pharmacokinetics and pharmacodynamics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324779
|Study Chair:||Alfred Reiter, MD||University Hospital Erlangen|