Leukemia, Lymphoma
Conditions
Keywords
B-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia, stage I childhood large cell lymphoma, stage II childhood large cell lymphoma, stage III childhood large cell lymphoma, stage IV childhood large cell lymphoma, stage I childhood lymphoblastic lymphoma, stage II childhood lymphoblastic lymphoma, stage III childhood lymphoblastic lymphoma, stage IV childhood lymphoblastic lymphoma, stage I childhood small noncleaved cell lymphoma, stage II childhood small noncleaved cell lymphoma, stage III childhood small noncleaved cell lymphoma, stage IV childhood small noncleaved cell lymphoma
Brief 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.
Interventions
BIOLOGICALrituximab
Sponsors
University Hospital Erlangen
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia * CD20 positive disease PATIENT CHARACTERISTICS: * 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 PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior corticosteroids * No prior radiotherapy * No prior or concurrent chemotherapy * No concurrent treatment in another investigational trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
| Effect of rituximab on different histological subtypes | — |
| Rituximab response | — |
| Toxicity | — |
| Pharmacokinetics and pharmacodynamics | — |
Countries
Germany, Switzerland
Outcome results
None listed