A Phase I/II Study of Oral Azacitidine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndromes after Receiving a Stem Cell Transplant from a Donor

Protocol
13-160
Full Title
A Phase 1/2, Dose and Schedule Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Oral Azacitidine (CC-486) in Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndromes after Allogeneic Hematopoietic Stem Cell Transplantation
Phase
I/II
Purpose

There is no standard treatment to maintain or improve the response a patient has to receiving a stem cell transplant from a donor. In this study, researchers are evaluating the safety and effectiveness of an oral (given by mouth) drug called azacitidine (also known as CC-486) in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who are receiving such “allogeneic” stem cell transplants.

An injected form of azacitidine is already approved for treating MDS and certain leukemias. The oral form of azacitidine is considered investigational. In this study, it is hoped that giving this drug to patients with AML or MDS following their transplants will lower the chance that their disease will return.

Eligibility

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

  • Patients must have AML or MDS and have had an allogeneic stem cell transplant.
  • Patients should be able to begin taking azacitidine 42 to 84 days following the transplant.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Esperanza Papadopoulos at 212-639-8276.

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