Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 10, 2011

Primary Completion Date

January 1, 2014

Study Completion Date

June 27, 2016

Conditions
Acute Myelogenous LeukemiaAcute Lymphocytic LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

atorvastatin

"donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines.~Patients-will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first."

DRUG

Tacrolimus

beginning on Day -2 through approximately Day +180 (that is, approximately 6 months after Day 0)

DRUG

methotrexate

Day +1, +3, and +6 and +11

Trial Locations (1)

43210

Ohio State University, Columbus

All Listed Sponsors
lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT01491958 - Safety & Efficacy of Atorvastatin for Prophylaxis of Acute Graft Versus Host Disease in Patients With Hematological Malignancies HLA- Donor Hematopoietic Stem Cell Transplantation | Biotech Hunter | Biotech Hunter