Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor
Recruitment status was: Recruiting
A. To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor, with fludarabine and low-dose TBI, with pre- and post-transplant immunosuppression with tacrolimus and MMF.
B. To evaluate the incidence of grade II-IV GVHD associated with this treatment.
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Drug: Tacrolimus and MMF
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants|
- The main endpoints are day 100 mortality and acute GVHD.
|Study Start Date:||March 2004|
- Days - 4 to -2: Fludarabine 30 mg/m2/day IV.
- Day 0: TBI 2.0 Gy at 6-7 cGy/min from a linear accelerator, followed by stem-cell infusion. TBI will preferably be administered between 7:00 a.m. and 1:00 p.m. to avoid proximity to tacrolimus/MMF administration.
Day -3: Start tacrolimus at 0.06 mg/kg PO BID. Day 0: Start MMF at 15 mg/kg PO b.i.d. from day 0 (PM dose only).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304720
|United States, Colorado|
|Rocky Mountain Blood and Marrow Transplant Program|
|Denver, Colorado, United States, 80218|
|Principal Investigator:||Peter A McSweeney, MD||Colorado Blood Cancer Institute|