Spots Global Cancer Trial Database for Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Official Title: Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
Study ID: NCT00324779
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Bremen, , Germany
Children's Hospital, Cologne, , Germany
Vestische Kinderklinik, Datteln, , Germany
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Universitaets - Kinderklinik, Erlangen, , Germany
Universitaetsklinikum Essen, Essen, , Germany
Klinikum der J.W. Goethe Universitaet, Frankfurt, , Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg, Freiburg, , Germany
Kinderklinik, Giessen, , Germany
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald, Greifswald, , Germany
University Medical Center Hamburg - Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitaets-Kinderklinik Heidelberg, Heidelberg, , Germany
Universitaetsklinikum des Saarlandes, Homburg, , Germany
Universitaets - Kinderklinik, Jena, , Germany
Staedtisches Klinikum Karlsruhe gGmbH, Karlsruhe, , Germany
Kinderkrankenhaus Park Schoenfeld, Kassel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus, Kiel, , Germany
Universitaets - Kinderklinik, Leipzig, , Germany
Universitaets - Kinderklinik - Luebeck, Luebeck, , Germany
Universitatsklinikum der MA, Magdeburg, , Germany
Universitaets - Kinderklinik, Marburg, , Germany
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster, Muenster, , Germany
Krankenhaus Muenchen Schwabing, Munich, , Germany
Dr. von Haunersches Kinderspital der Universitaet Muenchen, Munich, , Germany
Cnopf'sche Kinderklinik, Nuremberg, , Germany
Klinik St. Hedwig-Kinderklinik, Regensburg, , Germany
Olgahospital, Stuttgart, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm, Ulm, , Germany
Universitaets - Kinderklinik Wuerzburg, Wuerzburg, , Germany
University Children's Hospital, Zurich, , Switzerland
Contact Details
Name: Alfred Reiter, MD
Affiliation: University Hospital Erlangen
Role: STUDY_CHAIR
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