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

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

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.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Relapse free survival (RFS)
  • Complete Remission (CR)/Complete Remission with incomplete blood count recovery (CRi)
  • Safety and Tolerability
  • Healthcare Resource Utilization
  • Patient-reported outcomes utilizing the FACIT-Fatigue Scale and the EQ-5D
This is an international, multicentre, 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)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society