Trial Search Results

Efficacy of Oral Azacitidine Plus 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 currently not accepting patients for this trial.

Lead Sponsor:


Stanford Investigator(s):


  • Drug: 300 mg Oral Azacitidine
  • Drug: Placebo


Phase 3


Inclusion Criteria:

   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

Exclusion Criteria:

   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

Ages Eligible for Study

55 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting