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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00324779
Other study ID # CDR0000466643
Secondary ID B-NHL-BFM-Rituxi
Status Completed
Phase Phase 2
First received May 10, 2006
Last updated September 24, 2015
Start date March 2004

Study information

Verified date September 2015
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
rituximab


Locations

Country Name City State
Germany 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 Dr. von Haunersches Kinderspital der Universitaet Muenchen Munich
Germany Krankenhaus Muenchen Schwabing 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
Switzerland University Children's Hospital Zurich

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Erlangen

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate No
Primary Effect of rituximab on different histological subtypes No
Primary Rituximab response No
Primary Toxicity Yes
Primary Pharmacokinetics and pharmacodynamics No
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