Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 13, 2015

Primary Completion Date

June 17, 2020

Study Completion Date

June 17, 2021

Conditions
Leukemia, Erythroblastic, AcuteMyelodysplastic Syndromes
Interventions
DRUG

5-Azacytidine

"Patients will be given a five day course of subcutaneous 5-azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9,~-8 and -7. This will be administered on an outpatient basis if possible."

DRUG

Fludarabine

Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.

DRUG

Melphalan

Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Melphalan will be given at 140 mg/m2 IV on day -3.

DRUG

Alemtuzumab

Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.

RADIATION

Total Body Irradiation

Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Total Body Irradiation (TBI) will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3).

Trial Locations (1)

10021

Weill Cornell Medical College, New York

All Listed Sponsors
lead

Weill Medical College of Cornell University

OTHER

NCT02497404 - Azacytidine Prior to in Vivo T-cell Depleted Allo Stem Cell Transplant for Patients With Myeloid Malignancies in CR | Biotech Hunter | Biotech Hunter