Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Acute myeloid leukemia,, myelodysplastic syndromes,, CC-486, oral Azacitidine,, transplantation,, allogeneic,, HSCT.
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed Myelodysplastic Syndromes or Acute Myeloid Leukemia undergoing allogeneic hematopoietic stem cell transplantation with either peripheral blood or bone marrow as the source of hematopoietic stem cells
At the time of allogeneic HSCT:
- No prior allogeneic HSCT; and
- No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
- Bone marrow blast < 20% if MDS or ≤ 10% if AML; and
- Peripheral blood blast ≤ 5%
Be able to start study drug between 42 to 84 days following allogeneic HSCT
Post transplant bone marrow blast count ≤ 5% confirmed within 21 days prior to starting study therapy
Adequate engraftment within 14 days prior to starting study therapy:
- Absolute Neutrophil count (ANC) ≥ 1.0 x 10^9/L without daily use of myeloid growth factor; and
- Platelet count 75 x 10^9/L without platelet transfusion within one week.
Adequate organ function:
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x upper limit of normal (ULN)
- Serum bilirubin < 2 x ULN
- Serum creatinine < 2 x ULN
Adequate coagulation (Prothrombin time [PT] ≤ 15 seconds, Partial thromboplastin time (PTT) ≤ 40 seconds, and/or International normalized ratio [INR] ≤ 1.5)
Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL at screening).
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Must agree to follow protocol-specified pregnancy precautions
Exclusion Criteria:
Use of any of the following after transplantation and prior to starting oral azacitidine:
- Chemotherapeutic agents for chemotherapy
- Investigational agents/therapies
- Azacitidine, decitabine or other demethylating agents
- Lenalidomide, thalidomide and pomalidomide
Active Graft-versus-host disease (GVHD) grade II or higher
Any evidence of gastrointestinal (GI) GVHD
Concurrent use of corticosteroids equivalent of prednisone at a dose > 0.5 mg/kg
Known active viral infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
Active uncontrolled systemic fungal, bacterial or viral infection
Presence of malignancies, other than MDS or AML, within the previous 12 months
Significant active cardiac disease within the previous 6 months
Sites / Locations
- Memorial Sloan-Kettering Cancer Center.
- University Hospitals Cleveland Medical Center
- MD Anderson Cancer Center The University of Texas
- Fred Hutchinson Cancer Research Center
- Queen Elizabeth Hospital UHB NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
CC-486
Dose of 150 mg, 200 mg, or 300 mg once daily (QD) for the first 7, 10, or 14 days of each 28-day cycle, starting 42-84 days after transplantation.