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).

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

In brief

The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Oral azacitidine has significant activity in MDS and AML. Oral azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of oral azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.

Key facts

Study ID

NCT01835587

Run by

Celgene

People needed

31

Starts

2013-10-25

Expected to finish

2017-05-26

Last updated by the study team

2018-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan-Kettering Cancer Center. — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• MD Anderson Cancer Center The University of Texas — Houston, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Queen Elizabeth Hospital UHB NHS Foundation Trust — Birmingham, United Kingdom

Full record on ClinicalTrials.gov

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