Summary

for people ages 55 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

Details

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.

Keywords

Leukemia, Myeloid, Acute Maintenance therapy AML Acute Myeloid Leukemia oral Azacitidine best supportive care complete remission Leukemia Leukemia, Myeloid Azacitidine 300 mg Oral Azacitidine

Eligibility

You can join if…

Open to people ages 55 years and up

  1. Male or female subjects ≥ 55 years of age
  2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
  3. 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)
  4. 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:

  1. 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;
  2. 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;
  3. 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;
  4. Subjects currently in the in the Follow-up Phase will continue to be followed for survival in the EP;
  5. Subjects who have signed the informed consent for the EP of the study;
  6. Subjects who do not meet any of the criteria for study discontinuation

You CAN'T join if...

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

Locations

  • University of California San Francisco Fresno Campus
    Fresno California 93701 United States
  • Stanford Cancer Center
    Stanford California 94305-582 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01757535
Phase
Phase 3
Study Type
Interventional
Last Updated