Fludarabine, Bendamustine and Rituximab Conditioning for Patients With Lymphoid Malignancies
The goal of this clinical research study is to learn if bendamustine, when given with a stem cell transplant and chemotherapy (fludarabine and rituximab), can help the transplanted stem cells start to grow and make new blood cells in patients with leukemia and lymphoma. The safety of this combination will also be studied.
Procedure: Stem Cell Transplant (SCT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fludarabine, Bendamustine and Rituximab (FBR) Non-myeloablative Allogeneic Conditioning for Patients With Lymphoid Malignancies|
- Maximum Tolerated Dose (MTD) of Bendamustine [ Time Frame: Continual reassessment during first 30 days for dose limiting toxicity (DLT) ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Bendamustine + Chemotherapy + SCT
Bendamustine starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3. Rituximab dose of 375 mg/m^2 by vein over 5-7 hours on Day -13 and 1000 mg/m^2 on Day -6, Day +1 and Day +8 (1 time each week for four weeks). Fludarabine 30 mg/m^2 on Day -5 to Day -3. Infusion of donor blood stem cells - Stem Cell Transplant (SCT) - by vein over 30-45 minutes on Day 0.
Starting dose of 70 mg/m^2 by vein over 1 hour on Day -5 through Day -3.
Other Names:Drug: Rituximab
Dose of 375 mg/m^2 by vein over 5-7 hours on Day -13 and 1000 mg/m^2 on Day -6, Day +1 and Day +8 (1 time each week for four weeks).
Other Name: RituxanDrug: Fludarabine
30 mg/m^2 on Day -5 to Day -3.
Other Names:Procedure: Stem Cell Transplant (SCT)
Infusion of donor blood stem cells by vein over 30-45 minutes on Day 0.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00880815
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issa F. Khouri, MD, BS||UT MD Anderson Cancer Center|