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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.

NCT05907057 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2026-05-08

No results posted yet for this study

Summary

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).

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Ivosidenib 500mg Oral Tablet

Provided as tablets, taken orally as two 250mg tablets once daily.

DRUG

Azacitidine

Administered subcutaneously (SC) or intravenously (IV) at a dose of 75mg/m2/day for 7 days, either consecutively on Days 1-7 or discontinuously for Days 1-5 and 8-9 of each cycle. The 7 days of administration will occur at the beginning of every 4 week-long cycle.

Sponsors & Collaborators

  • Servier Affaires Médicales

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2027-10-15
Completion
2027-10-15
FDA Drug
Yes

Countries

  • Austria
  • France
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907057 on ClinicalTrials.gov