Spots Global Cancer Trial Database for Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor

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Trial Identification

Brief Title: Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor

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

Study ID: NCT00304720

Conditions

Multiple Myeloma

Lymphoma

Acute Myelogenous Leukemia

Acute Lymphocytic Leukemia

Myelodysplastic Syndrome

Interventions

Tacrolimus and MMF

Study Description

Brief Summary: Primary Objective: 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.

Detailed Description: Conditioning regimen: 1. Days - 4 to -2: Fludarabine 30 mg/m2/day IV. 2. 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. Immunosuppression: 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).