Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant

NACompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

December 31, 2013

Study Completion Date

June 30, 2014

Conditions
Leukemia
Interventions
DRUG

5-azacitidine

Once enrolled, the patients will receive pre-transplant 5-azacitidine (Vidaza) 75 mg/M\^2/day subcutaneously for 5-7 days every 28 days). Adjustments in dose and timing may occur based on clinical and hematological parameters.

PROCEDURE

Allogeneic Hematopoietic Cell Transplantation (HCT)

"Patients will receive transplantation if there is either a suitable sibling or an unrelated donor.~* Response will be evaluated by bone marrow biopsy after 4 cycles of 5-azacitidine or prior to HCT whichever comes first. Due to the very high risk of progression to AML or death in this patient population, the HCT will be done as soon as possible.~* The patients may have additional cycles of 5-azacitidine per standard hematology practice until scheduled for transplant or until progression of disease.~* All patients will be followed until time to progression of MDS, AML or death or a maximum of 1 year. For patients that are transplanted, follow up will be to one year post-transplant."

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00660400 - Pre-Transplant 5-Azacitidine In Patients With High-Risk Myelodysplastic Syndrome Who Are Candidates For Allogeneic Hematopoietic Cell Transplant | Biotech Hunter | Biotech Hunter