A Phase II Study of 5'-Azacitidine to Prevent Recurrence in Patients Who Had a Donated Stem Cell Transplant for Acute Myeloid Leukemia or Myelodysplastic Syndromes

Protocol
13-192
Full Title
A Single Arm Phase II Trial of 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
Phase
II
Purpose

5’-Azacitidine is a drug already approved for the treatment of acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), including patients whose disease returned after having a stem cell transplant. However, it is unclear if 5’-azacitidine can prevent disease recurrence in patients who achieved remission after having an allogeneic (donated) stem cell transplant for AML or MDS.

The purpose of this study is to evaluate the safety and effectiveness of 5’-azacitidine for preventing recurrence in children and adults who are in remission after allogeneic stem cell transplantation for AML or MDS but who are at high risk of disease recurrence.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be at least 1 year of age and no older than age 75.
  • Patients must have achieved remission after receiving a T cell-depleted allogeneic stem cell transplant for AML or MDS.
  • Patients should enter the study 60 to 120 days after their transplant.

For more information and to inquire about eligibility for this study, please contact Dr. Hugo Castro-Malaspina at 212-639-8197.

Disease(s)
Hematology: Myelodysplastic Syndrome
Leukemia: Acute Myelocytic Leukemia
Locations