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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Kinderklinik - Universitaetsklinikum Aachen
Aachen, Germany
Klinikum Augsburg
Augsburg, Germany
Charite - Campus Charite Mitte
Berlin, Germany
Helios Klinikum Berlin
Berlin, Germany
Evangelisches Krankenhauus Bielfeld
Biefeld, Germany
Klinikum Bremen-Mitte
Response rate
Effect of rituximab on different histological subtypes
Rituximab response
Toxicity
Pharmacokinetics and pharmacodynamics
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bremen, Germany
Children's Hospital
Cologne, Germany
Vestische Kinderklinik
Datteln, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Helios Klinikum Erfurt
Erfurt, Germany
...and 28 more locations