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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 13-007675
    NCT ID: NCT01757535
    Sponsor Protocol Number: CC-486-AML-001

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aref Al-Kali, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions