Status:
COMPLETED
Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Lead Sponsor:
University Hospital Erlangen
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
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 t...
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 u...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00324779
Start Date
March 1 2004
Last Update
September 25 2015
Active Locations (38)
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1
Kinderklinik - Universitaetsklinikum Aachen
Aachen, Germany, D-52074
2
Klinikum Augsburg
Augsburg, Germany, DOH-86156
3
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
4
Helios Klinikum Berlin
Berlin, Germany, D-13125