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Bone Marrow Transplant

Oral Azacitidine (CC-486) in Subjects with Acute Myeloid Leukemia or Myelodysplastic Syndromes post Allogeneic Transplant (2709)
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
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia
Myelodysplastic and Myeloproliferative Syndromes
Phase I/II 2709
NCT01835587
Summary

The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486 (also known as oral Azacitidine) in patients with AML or MDS after allogeneic HSCT. Allogeneic hematopoietic stem cell transplantation (HSCT) is more frequently used in Acute Myloid leukemia (AML) or Myelodysplastic Syndromes (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. Azacitidine has significant activity in MDS and AML. Azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of Azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.


Investigator
Bart Scott, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Histologically confirmed (Myelodysplastic Syndromes) MDS or Acute Myeloid Leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT) 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 therapy 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:

  • Absoulute Neutrophil count (ANC) ≥ 1.0 x 109/L without daily use of myeloid growth factor; and
  • Platelet ≥ 25 x 109/L without platelet transfusion within 1 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)

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Must agree to follow protocol-specified pregnancy precautions

Exclusions (conditions that would prevent participation in this study)
  • 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

Other exclusion criteria may apply.

Last Updated
July 07, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.