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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00324779
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : September 25, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: rituximab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 79 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy
Study Start Date : March 2004
Actual Primary Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rituximab

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Response rate
  2. Effect of rituximab on different histological subtypes
  3. Rituximab response
  4. Toxicity
  5. Pharmacokinetics and pharmacodynamics

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324779


Locations
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Sponsors and Collaborators
University Hospital Erlangen
Investigators
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Study Chair: Alfred Reiter, MD University Hospital Erlangen
More Information
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ClinicalTrials.gov Identifier: NCT00324779    
Other Study ID Numbers: CDR0000466643
B-NHL-BFM-Rituximab
EU-205119
NHL-BFM-RITUXIMAB
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: September 25, 2015
Last Verified: September 2015
Keywords provided by National Cancer Institute (NCI):
B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia
stage I childhood large cell lymphoma
stage II childhood large cell lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
stage I childhood lymphoblastic lymphoma
 stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
stage I childhood small noncleaved cell lymphoma
stage II childhood small noncleaved cell lymphoma
stage III childhood small noncleaved cell lymphoma
stage IV childhood small noncleaved cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Leukemia, Lymphoid
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents