Lymphoma Clinical Trial
Official title:
Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
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.
OBJECTIVES:
- 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.
;
Masking: Open Label, Primary Purpose: Treatment
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