Status:
COMPLETED
Rituximab, Carmustine; Cytarabine, Etoposide, & Melphalan; Stem Cell Transplantation for Non-Hodgkin's Lymphoma
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
19-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy,...
Detailed Description
OBJECTIVES: * Determine the levels of soluble CD20 antigen (sCD20) in the blood before and after treatment with rituximab and carmustine, cytarabine, etoposide, and melphalan followed by autologous h...
Eligibility Criteria
Inclusion
- Diagnosis of non-Hodgkin's lymphoma
- o Any B cell
- CD20-positive disease
- Failed prior primary induction therapy
- Meets 1 of the following criteria:
- Chemotherapy-refractory disease
- Received at least 3 prior chemotherapy regimens
- Mantle cell lymphoma
- Eligible for transplantation
- 19 years old and over
- WHO 0-2
- Life expectancy at least 6 months
- Absolute neutrophil count ≥ 1,000/mm\^3\*
- Platelet count \> 50,000/mm\^3\*
- Hemoglobin \> 9.0 g/dL\*
- o NOTE: \*Unless due to lymphomatous involvement of the bone marrow
- Fertile patients must use 2 methods of effective contraception
Exclusion
- No history of T-cell lymphoma
- Not pregnant or nursing
- No other concurrent serious disease or condition that would preclude study participation
Key Trial Info
Start Date :
May 8 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2015
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00080886
Start Date
May 8 2002
End Date
March 12 2015
Last Update
October 6 2023
Active Locations (1)
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1
University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, United States, 68198-7680