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Clinical Trials (PDQ®)

Phase II Study of Rituximab as Upfront Window Therapy Before Chemotherapy in Pediatric Patients With Mature B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedUnder 19OtherB-NHL-BFM-Rituximab
EU-205119, NHL-BFM-RITUXIMAB, NCT00324779

Objectives

  1. 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.
  2. Evaluate the effect of rituximab on different histological subtypes of childhood mature B-NHL or B-ALL in patients treated with this regimen.
  3. Investigate the rituximab response in patients treated with this regimen.
  4. Determine the toxicity profile of rituximab in these patients.
  5. Collect pharmacokinetic and pharmacodynamic data from patients treated with this regimen.

Entry Criteria

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

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

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

Expected Enrollment

79

A total of 79 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

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

Outline

This is a multicenter study.

Patients receive rituximab IV on day 1.

Trial Contact Information

Trial Lead Organizations

Kinderklinik

Alfred Reiter, MD, Protocol chair
Ph: 49-641-994-3420

Registry Information
Official Title Multicenter Therapy Study for Children with Mature B-NHL or B-ALL with a Rituximab - Window Before Chemotherapy
Trial Start Date 2004-03-01
Registered in ClinicalTrials.gov NCT00324779
Date Submitted to PDQ 2006-01-06
Information Last Verified 2007-11-19

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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