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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.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 10, 2006
Last updated: September 24, 2015
Last verified: September 2015

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:


  • 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.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically and immunohistochemically OR cytomorphologically and immunphenotypically confirmed mature B-cell non-Hodgkin's lymphoma or B-cell acute lymphoblastic leukemia
  • CD20 positive disease


  • 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


  • 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
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Please refer to this study by its identifier: NCT00324779

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
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
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
University Children's Hospital
Zurich, Switzerland, CH-8032
Sponsors and Collaborators
University Hospital Erlangen
Study Chair: Alfred Reiter, MD University Hospital Erlangen
  More Information Identifier: NCT00324779     History of Changes
Other Study ID Numbers: CDR0000466643
Study First Received: May 10, 2006
Last Updated: September 24, 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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Burkitt Lymphoma
Neoplasms by Histologic Type
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
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 21, 2017