OncoMatch/Clinical Trials/NCT05401097
IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)
Is NCT05401097 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Enasidenib for acute myeloid leukemia.
Treatment: Azacitidine · Enasidenib · Ivosidenib · Venetoclax — This phase II study compares the order of treatment with ivosidenib or enasidenib and azacitidine plus venetoclax in treating older patients with acute myeloid leukemia with genetic changes in the IDH1 or IDH2 genes (IDH mutated). Ivosidenib is in a class of medications called isocitrate dehydrogenase-1 (IDH1) inhibitors. It works by slowing or stopping the growth of cancer cells. Enasidenib is in a class of medications called an IDH2 inhibitor. It also works by slowing or stopping the growth of cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. This study may help researchers determine which treatment order is best for older patients with IDH mutated acute myeloid leukemia: 1) ivosidenib or enasidenib followed by azacitidine plus venetoclax; or 2) azacitidine plus venetoclax followed by ivosidenib or enasidenib.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 mutation
Required: IDH2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: investigational drug trial with therapeutic intent
Concurrent participation in an investigational drug trial with therapeutic intent defined as prior study therapy within 14 days prior to study treatment
Lab requirements
Kidney function
Creatinine clearance > 40 ml/min
Liver function
AST/ALT < 5 x upper limit of normal; total bilirubin < 1.5 x upper limit of normal (except for patients with Gilbert's disease)
Creatinine clearance > 40 ml/min; AST/ALT < 5 x upper limit of normal; total bilirubin < 1.5 x upper limit of normal (except for patients with Gilbert's disease)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
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