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

Lymphoma Clinical Trial

Official title:

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

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. 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

• Burkitt Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

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