# An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.

Source: https://onco.cc/trials/nct05907057/  
OnCo record `nct05907057` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Ivosidenib and Azacitidine in acute myeloid leukaemia, run by Servier Affaires Médicales, now recruiting.

## Summary

An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy. is a phase 3 interventional study registered as NCT05907057 by Servier Affaires Médicales, with 245 participants planned, started 2023-06-14 and due to reach its primary completion in 2027-10-15. Interventions recorded: Ivosidenib 500mg Oral Tablet and Azacitidine.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05907057
- Phase: 3
- Setting: A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy
- Sponsor: Servier Affaires Médicales
- Enrolled: 245

## Sources

- ClinicalTrials.gov NCT05907057: https://clinicaltrials.gov/study/NCT05907057

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- drugs: [Azacitidine](https://onco.cc/drugs/azacitidine/), [Ivosidenib](https://onco.cc/drugs/ivosidenib/)

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JSON: https://onco.cc/api/v1/entities/nct05907057.json