Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.
Procedure: Autologous stem cell transplant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma|
- response rate [ Time Frame: 100 day ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: diagnosis until death ] [ Designated as safety issue: No ]
|Study Start Date:||May 1998|
|Study Completion Date:||September 2009|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
|Experimental: Arm I||
375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
Other Name: RituximabDrug: BEAM
BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1Procedure: Autologous stem cell transplant
following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line
Objectives: I. To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To determine if the addition of Rituxan changes the toxicity profile attributed to high-dose BEAM chemotherapy.
This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent to aid in the chemotherapy sensitization and the treatment of minimal residual disease post-transplant.
|United States, Nebraska|
|University of Nebraska Medical Center, Section of Oncology/Hematology|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Julie M Vose, M.D.||University of Nebraska|