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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Notify MeKey information
Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Kinderklinik - Universitaetsklinikum Aachen, Aachen, Germany
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
Primary outcomes
-
Response rate
-
Effect of rituximab on different histological subtypes
-
Rituximab response
-
Toxicity
-
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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