Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

September 27, 2023

Study Completion Date

September 27, 2023

Conditions
Myelodysplastic Syndromes (MDS)Acute Myelogenous Leukemia (AML)
Interventions
DRUG

low dose 5'-azacitidine

5'-azacitadine will be given at a low dose of 32mg/m2 S.C for 5 days every 28 days (a cycle). Dose de-escalation will be permitted for hematologic and non- hematologic toxicities. Patients will start taking the study drug between days 60-120 post TCD allogeneic hematopoietic stem cell transplant and up to a year post-transplant or until there is a toxicity that requires cessation of therapy. Therefore patients will get between 8-10 cycles. Patients who come off-study for reasons unrelated to toxicities before completing 4 cycles will be replaced Since most cases of relapse occur early post transplant, in the first year, this is the most appropriate time to intervene. Treatment will start as soon as possible.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Consent and Follow-up), Harrison

11725

Memorial Sloan Kettering Commack (Consent and Follow-up), Commack

07920

Memorial Sloan Kettering at Basking Ridge (Consent and Follow-up), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Consent and Follow-up), Middletown

07645

Memorial Sloan Kettering Bergen (Consent and Follow-up), Montvale

Unknown

Memorial Sloan Kettering Nassau (Consent and Follow-up), Rockville Centre

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01995578 - Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse | Biotech Hunter | Biotech Hunter