🏛️ Verified NIH Record • Updated 2026-02-09

A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission (NCT05197426)

A Phase 2, 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 Japanese Subjects With Acute Myeloid Leukemia in Complete Remission

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Bristol-Myers Squibb

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Who can join: Review the eligibility criteria below.

Location: Local Institution - 0011 — Huntsville, Alabama

Age range: 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (31 Sites)

Showing the first 25 of 31 sites.

  • Local Institution - 0011 — Huntsville, Alabama
  • Local Institution - 0017 — Nagoya, Aichi-ken
  • Local Institution - 0023 — Nagoya, Aichi-ken
  • Local Institution - 0009 — Toyoake, Aichi-ken
  • Local Institution - 0022 — Aomori, Aomori
  • Local Institution - 0005 — Kamogawa, Chiba
  • Local Institution - 0003 — Kashiwa-shi, Chiba
  • Local Institution - 0010 — Matsuyama, Ehime
  • Local Institution - 0020 — Yoshida Gun, Fukui
  • Local Institution - 0016 — Fukuoka, Fukuoka
  • Local Institution - 0014 — Ōgaki, Gifu
  • Local Institution - 0001 — Maebashi, Gunma
  • Local Institution - 0004 — Sapporo, Hokkaido
  • Local Institution - 0019 — Kanazawa, Ishikawa-ken
  • Local Institution - 0012 — Isehara, Kanagawa
  • Local Institution - 0006 — Sagamihara-shi, Kanagawa
  • Local Institution - 0013 — Yokohama, Kanagawa
  • Local Institution - 0015 — Sendai, Miyagi
  • Local Institution - 0026 — Osaka, Osaka
  • Local Institution - 0021 — Ōsaka-sayama, Osaka
  • Local Institution - 0031 — Shimotsuke, Tochigi
  • Local Institution - 0032 — Bunkyo Ku, Tokyo
  • Local Institution - 0002 — Shinagawa, Tokyo
  • Local Institution - 0030 — Shinjuku-ku, Tokyo
  • Local Institution - 0029 — Sumida Ku, Tokyo

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗