Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia

NCT ID: NCT00324779

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31

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.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rituximab

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Erlangen

OTHER

Sponsor Role: lead

Principal Investigators

Alfred Reiter, MD

Role: STUDY_CHAIR

University Hospital Erlangen

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 im Breisgau, , 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

Hanover, , 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

Lübeck, , Germany

Universitatsklinikum der MA

Magdeburg, , Germany

Universitaets - Kinderklinik

Marburg, , Germany

Krankenhaus Muenchen Schwabing

Munich, , Germany

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, , Germany

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, , Germany

Cnopf'sche Kinderklinik

Nuremberg, , Germany

Klinik St. Hedwig-Kinderklinik

Regensburg, , Germany

Olgahospital

Stuttgart, , Germany

Universitaetsklinikum Tuebingen

Tübingen, , Germany

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, , Germany

Universitaets - Kinderklinik Wuerzburg

Würzburg, , Germany

University Children's Hospital

Zurich, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

B-NHL-BFM-Rituximab

Identifier Type: -

Identifier Source: secondary_id

EU-205119

Identifier Type: -

Identifier Source: secondary_id

NHL-BFM-RITUXIMAB

Identifier Type: -

Identifier Source: secondary_id

CDR0000466643

Identifier Type: -

Identifier Source: org_study_id