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OpenTrials
Completed

NCT Number: NCT00324779

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Biological

Primary outcomes

  1. Response rate

  2. Effect of rituximab on different histological subtypes

  3. Rituximab response

  4. Toxicity

  5. Pharmacokinetics and pharmacodynamics

Sponsors and collaborators

Lead sponsor

University Hospital Erlangen

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2011
First posted
May 11, 2006
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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