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).
|United States, Colorado|
|Rocky Mountain Blood and Marrow Transplant Program||Recruiting|
|Denver, Colorado, United States, 80218|
|Contact: Peter A McSweeney, MD 303-336-2184 Peter.McSweeney@usoncology.com|
|Contact: Juli B Murphy 303-285-5087 Juli.Murphy@usoncology.com|
|Sub-Investigator: Robert M Rifkin, MD|
|Principal Investigator: Peter A McSweeney, MD|
|Sub-Investigator: Jeffrey V Matous, MD|
|Sub-Investigator: Scott I Bearman, MD|
|Sub-Investigator: Mark W Brunvand, MD|
|Sub-Investigator: Michael B Maris, MD|
|Principal Investigator:||Peter A McSweeney, MD||Rocky Mountain Blood and Marrow Transplant Program|