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

September 24, 2015 updated by: University Hospital Erlangen

Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Response rate
Effect of rituximab on different histological subtypes
Rituximab response
Pharmacokinetics and pharmacodynamics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Erlangen

Investigators

  • Study Chair: Alfred Reiter, MD, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

April 1, 2011

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000466643
  • B-NHL-BFM-Rituximab
  • EU-205119
  • NHL-BFM-RITUXIMAB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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