Skip to main content

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

Trial Status: Closed to Accrual

This study will enroll approximately 460 subjects, aged 55 or older, with a diagnosis of de novo AML (Acute Myeloid Leukemia) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first Complete remission (CR) / Complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an Extension Phase (EP). The EP allows subjects who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receive oral azacitidine after unblinding by Sponsor (Celgene Corporation) until the subject meets the criteria for study discontinuation or until oral azacytidine becomes commercially available and reimbursed. In addition, all subjects in the placebo arm and subjects who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the Follow-up Phase will be followed for survival in the EP.

Inclusion Criteria

  • Male or female subjects ≥ 55 years of age
  • Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
  • First Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)
  • Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3 Inclusion Criteria in the Extended Phase of the study: At the Investigator's discretion and with approval of the sponsor, subjects meeting all of the following eligibility criteria are eligible to enter the extension phase:
  • All subjects randomized into the oral azacitidine or placebo arm and are continuing in either the Treatment Phase or Follow-up Phase of the CC-486-AML-001 study;
  • Subjects randomized to oral azacitidine treatment arm and continuing in the Treatment Phase demonstrating clinical benefit as assessed by the Investigator are eligible to receive oral azacitidine in the EP;
  • Subjects randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP;
  • Subjects currently in the in the Follow-up Phase will continue to be followed for survival in the EP;
  • Subjects who have signed the informed consent for the EP of the study;
  • Subjects who do not meet any of the criteria for study discontinuation

Exclusion Criteria

  • AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations
  • Prior bone marrow or stem cell transplantation
  • Have achieved CR/CRi following therapy with hypomethylating agents
  • Diagnosis of malignant disease within the previous 12 months
  • Proven Central Nervous System (CNS) leukemia

California

Duarte
City of Hope Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ADMINISTRATIVELY_COMPLETE

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: COMPLETED

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

Nebraska

Omaha
University of Nebraska Medical Center
Status: COMPLETED

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: COMPLETED

New York

New York
Icahn School of Medicine at Mount Sinai
Status: COMPLETED
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: COMPLETED

North Carolina

Durham
Duke University Medical Center
Status: COMPLETED
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: APPROVED
Contact: Michael Boyiadzis
Phone: 412-647-8073

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

This is an international, multicenter, placebo-controlled, Phase 3 study with a double-blind,

randomized, parallel-group design in subjects with de novo AML or AML secondary to prior

diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) aged ≥

55 years, who are in first CR/CRi following induction therapy with or without consolidation

chemotherapy. The study consists of 3 phases; the Pre-randomization Phase (Screening Phase),

the Treatment Phase, and the Follow-up Phase.

The study is amended to include an Extension Phase (EP). The EP allows subjects who are

currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed

by the Investigator, to continue receive oral azacitidine after unblinding by Sponsor

(Celgene Corporation) until they meet the criteria for study discontinuation or until oral

azacitidine becomes commercially available and reimbursed. In addition, all subjects in the

placebo arm and subjects who had been discontinued from the treatment phase (irrespective of

randomization arm) and continuing in the Follow-up Phase will be followed for survival in the

EP.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Celgene Corporation

  • Primary ID CC-486-AML-001
  • Secondary IDs NCI-2013-00084, 2012-003457-28
  • Clinicaltrials.gov ID NCT01757535