OncoMatch/Clinical Trials/NCT05907057
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 NCT05907057 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Ivosidenib 500mg Oral Tablet and Azacitidine for acute myeloid leukemia (aml).
Treatment: Ivosidenib 500mg Oral Tablet · Azacitidine — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 r132 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: IDH1 inhibitor
Has received prior treatment with an IDH1 inhibitor
Lab requirements
Kidney function
adequate renal (kidney) function; creatinine clearance less than 45 mL/minute makes patient ineligible for intensive chemotherapy
Liver function
adequate hepatic (liver) function; bilirubin greater than 1.5 times the upper limit of normal makes patient ineligible for intensive chemotherapy
Has adequate hepatic (liver) and renal (kidney) function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05907057 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require IDH1?
Yes, IDH1 r132 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages