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

Phase 2

Completed

• Conditions: Leukemia; Lymphoma

• Registration Number: NCT00324779
• Lead Sponsor: University Hospital Erlangen

Brief 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.

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-05-10
• Study First Submitted QC: 2006-05-10
• Study First Posted: 2006-05-11
• Primary Completion: 2011-04
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate
Effect of rituximab on different histological subtypes
Pharmacokinetics and pharmacodynamics
Rituximab response
Toxicity

Trial Locations

Locations (35)

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

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