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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. Subjects who have previously achieved CR/CRi with a hypomethylating agent will be excluded from the study.

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, phase3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplasic Syndromes (MDS) or chronic myelomonocytic leukemia (CMML)

Keywords

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

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
  • Providence St Joseph Medical Center Cancer Center
    Burbank, California, 91505, United States
  • University of Southern California Norris Cancer Center
    Los Angeles, California, 90033, United States
  • City of Hope
    Duarte, California, 91010-301, United States
  • Innovative Clinical Research Institute
    Whittier, California, 90603, United States
  • UCLA
    Los Angeles, California, 90095-6956, United States
  • UC Irvine
    Orange, California, 92868, 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
November 2, 2017