# Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

> **NCT03173248** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Institut de Recherches Internationales Servier** · enrollment: 146 (actual)

## Conditions studied

- Newly Diagnosed Acute Myeloid Leukemia (AML)
- Untreated AML
- AML Arising From Myelodysplastic Syndrome (MDS)
- Leukemia, Myeloid, Acute

## Interventions

- **DRUG:** AG-120
- **DRUG:** Placebo
- **DRUG:** Azacitidine

## Key facts

- **NCT ID:** NCT03173248
- **Lead sponsor:** Institut de Recherches Internationales Servier
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2017-06-26
- **Primary completion:** 2021-03-18
- **Final completion:** 2026-06-30
- **Target enrollment:** 146 (ACTUAL)
- **Last updated:** 2025-11-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03173248

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03173248, "Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03173248. Licensed CC0.

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