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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

The purpose of this study is to determine the effect of oral Azacitidine on Acute Myeloid Leukemia (AML). The study also aims to learn more about the safety and effectiveness of the study drug.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Placebo
  • drug : 300 mg Oral Azacitidine

Phase: Phase 3

Eligibility

Ages Eligible For Study:

55 Years - N/A

Inclusion Criteria

1. Male or female subjects ? 55 years of age 2. Newly diagnosed, confirmed de novo AML or AML Secondary to prior myolodysplasic 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 4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

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