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:

Celgene

Stanford Investigator(s):

Intervention(s):

  • Drug: 300 mg Oral Azacitidine
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

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;

      - 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;

      - 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;

      - Subjects currently in the in the Follow-up Phase will continue to be followed for
      survival in the EP;

   2. Subjects who have signed the informed consent for the EP of the study;

   3. Subjects who do not meet any of the criteria for study discontinuation

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

All

Not currently accepting new patients for this trial

Contact Information

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