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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324779
First Posted: May 11, 2006
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Leukemia Lymphoma Biological: rituximab Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate
  • Effect of rituximab on different histological subtypes
  • Rituximab response
  • Toxicity
  • Pharmacokinetics and pharmacodynamics

Estimated Enrollment: 79
Study Start Date: March 2004
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324779


Locations
Germany
Kinderklinik - Universitaetsklinikum Aachen
Aachen, Germany, D-52074
Klinikum Augsburg
Augsburg, Germany, DOH-86156
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
Helios Klinikum Berlin
Berlin, Germany, D-13125
Evangelisches Krankenhauus Bielfeld
Biefeld, Germany, 33617
Klinikum Bremen-Mitte
Bremen, Germany, D-28205
Children's Hospital
Cologne, Germany, D-50924
Vestische Kinderklinik
Datteln, Germany, 45704
Universitatsklinikum Carl Gustav Carus
Dresden, Germany, D-01307
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Universitaets - Kinderklinik
Erlangen, Germany, 91054
Universitaetsklinikum Essen
Essen, Germany, D-45147
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
Kinderklinik
Giessen, Germany, D-35385
Klinik und Poliklinik Fuer Kinder-und Jugendmedizin - Universitaetsklinikum Greifswald
Greifswald, Germany, 17475
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Universitaets-Kinderklinik Heidelberg
Heidelberg, Germany, D-69120
Universitaetsklinikum des Saarlandes
Homburg, Germany, 66421
Universitaets - Kinderklinik
Jena, Germany, D-07440
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Kinderkrankenhaus Park Schoenfeld
Kassel, Germany, D-34121
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Universitaets - Kinderklinik
Leipzig, Germany, D-04317
Universitaets - Kinderklinik - Luebeck
Luebeck, Germany, D-23538
Universitatsklinikum der MA
Magdeburg, Germany, 39120
Universitaets - Kinderklinik
Marburg, Germany, 35033
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Muenster, Germany, D-48149
Krankenhaus Muenchen Schwabing
Munich, Germany, 80804
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, Germany, D-80337
Cnopf'sche Kinderklinik
Nuremberg, Germany, 90419
Klinik St. Hedwig-Kinderklinik
Regensburg, Germany, 93049
Olgahospital
Stuttgart, Germany, D-70176
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, D-89075
Universitaets - Kinderklinik Wuerzburg
Wuerzburg, Germany, D-97080
Switzerland
University Children's Hospital
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Hospital Erlangen
Investigators
Study Chair: Alfred Reiter, MD University Hospital Erlangen
  More Information

ClinicalTrials.gov Identifier: NCT00324779     History of Changes
Other Study ID Numbers: CDR0000466643
B-NHL-BFM-Rituximab
EU-205119
NHL-BFM-RITUXIMAB
First Submitted: May 10, 2006
First Posted: May 11, 2006
Last Update Posted: September 25, 2015
Last Verified: September 2015

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents