Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
- Conditions
- LeukemiaLymphoma
- Registration Number
- NCT00324779
- Lead Sponsor
- University Hospital Erlangen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate Effect of rituximab on different histological subtypes Toxicity Pharmacokinetics and pharmacodynamics Rituximab response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Klinikum Bremen-Mitte
🇩🇪Bremen, Germany
University Medical Center Hamburg - Eppendorf
🇩🇪Hamburg, Germany
Olgahospital
🇩🇪Stuttgart, Germany
University Children's Hospital
🇨ðŸ‡Zurich, Switzerland
Helios Klinikum Berlin
🇩🇪Berlin, Germany
Universitaets - Kinderklinik Wuerzburg
🇩🇪Wuerzburg, Germany
Kinderkrankenhaus Park Schoenfeld
🇩🇪Kassel, Germany
Vestische Kinderklinik
🇩🇪Datteln, Germany
Kinderklinik - Universitaetsklinikum Aachen
🇩🇪Aachen, Germany
Klinik St. Hedwig-Kinderklinik
🇩🇪Regensburg, Germany
Children's Hospital
🇩🇪Cologne, Germany
Universitaets-Kinderklinik Heidelberg
🇩🇪Heidelberg, Germany
Staedtisches Klinikum Karlsruhe gGmbH
🇩🇪Karlsruhe, Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Universitaets - Kinderklinik
🇩🇪Marburg, Germany
Kinderklinik
🇩🇪Giessen, Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg
🇩🇪Freiburg, Germany
University Hospital Schleswig-Holstein - Kiel Campus
🇩🇪Kiel, Germany
Universitaets - Kinderklinik - Luebeck
🇩🇪Luebeck, Germany
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
🇩🇪Greifswald, Germany
Universitaetsklinikum des Saarlandes
🇩🇪Homburg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Evangelisches Krankenhauus Bielfeld
🇩🇪Biefeld, Germany
Klinikum der J.W. Goethe Universitaet
🇩🇪Frankfurt, Germany
Universitatsklinikum der MA
🇩🇪Magdeburg, Germany
Dr. von Haunersches Kinderspital der Universitaet Muenchen
🇩🇪Munich, Germany
Cnopf'sche Kinderklinik
🇩🇪Nuremberg, Germany
Charite - Campus Charite Mitte
🇩🇪Berlin, Germany
Krankenhaus Muenchen Schwabing
🇩🇪Munich, Germany