Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (NCT03173248)
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
🩺 Plain-English Summary (8th-Grade Level)
Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.
Who can join: Review the eligibility criteria below.
Location: Norton Cancer Institute - Suburban — Louisville, Kentucky
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (90 Sites)
Showing the first 25 of 90 sites.
- Norton Cancer Institute - Suburban — Louisville, Kentucky
- Massachusetts General Hospital — Boston, Massachusetts
- Royal Prince Alfred Hospital — Camperdown, New South Wales
- Royal Adelaide Hospital — Adelaide, South Australia
- Flinders Medical Centre — Bedford Park, South Australia
- Salzburger Landeskliniken — Salzburg,
- Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel — Vienna,
- Unicamp Universidade Estadual de Campinas — Campinas, São Paulo
- Hospital Amaral Carvalho — Jaú, São Paulo
- Instituto Nacional de Cancer — Rio de Janeiro,
- Hospital Sirio Libanes — São Paulo,
- Hospital Sao Jose — São Paulo,
- Hospital Santa Marcelina — São Paulo,
- Cancer Care Manitoba — Winnipeg, Manitoba
- University Health Network — Toronto, Ontario
- Henan Cancer Hospital — Zhengzhou, Henan
- West China Hospital Sichuan University — Chengdu, Sichuan
- Peking Union Medical College Hospital — Beijing,
- Guangdong Provincial People's Hospital — Guangzhou,
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou,
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin,
- Fakultni nemocnice Ostrava — Ostrava,
- Hopital Haut Leveque — Pessac, Gironde
- Hopital Bretonneau — Tours, Indre-et-Loire
- Hotel Dieu - Nantes — Nantes, Loire-Atlantique
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.