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NCT05907057 · ClinicalTrials.gov record · last posted 2026-05-08

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.

StatusRecruiting
PhasePhase 3
Started2023-06-14
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from the ClinicalTrials.gov record
The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \[IDH1m\]) and cannot receive treatment with intensive chemotherapy (IC).

Amendment record 5 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 5 times since 2023-06-08; most recent amendment 2026-05-06. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-07-13
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT05907057
Lead Sponsor Servier Affaires Médicales
Conditions Acute Myeloid Leukemia (AML)
Enrollment 245 participants
Start Date 2023-06-14
Primary Completion 2027-10-15 (estimated)
Study Completion 2027-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-08