Status:
COMPLETED
VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them fro...
Detailed Description
OBJECTIVES: * Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without rituximab influences CD34+ cell yield in patients undergoing autologous peripheral blood stem cell t...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Patients with B-cell malignancies who are appropriate candidates for high-dose chemotherapy and autologous stem cell transplantation and meet 1 of the following criteria:
- Relapsed or refractory B-cell non-Hodgkin's Lymphoma (NHL)
- Patients with B-cell NHL in first remission and who have significant risk for later relapse
- Patients with other B-cell malignancies otherwise eligible for autologous stem cell transplantation
- PATIENT CHARACTERISTICS:
- Life expectancy at least 2 months
- Cardiac ejection fraction ≥ 45%
- DLCO ≥ 45%
- Creatinine \< 2.0 mg/dL
- Bilirubin \< 2.0 mg/dL
- AST \< 2 times normal
- Platelet count ≥ 50,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Absolute lymphocyte count ≤ 10,000/mm\^3
- HIV negative
- No severe medical or psychiatric illnesses
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- More than 8 weeks since prior rituximab
Exclusion
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00274794
Start Date
February 1 2000
End Date
May 1 2006
Last Update
March 29 2011
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195