Trials / Completed
CompletedNCT00324779
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 79 (estimated)
- Sponsor
- University Hospital Erlangen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rituximab |
Timeline
- Start date
- 2004-03-01
- Primary completion
- 2011-04-01
- First posted
- 2006-05-11
- Last updated
- 2015-09-25
Locations
38 sites across 2 countries: Germany, Switzerland
Source: ClinicalTrials.gov record NCT00324779. Inclusion in this directory is not an endorsement.