OncoMatch/Clinical Trials/NCT07075016
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Is NCT07075016 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Venetoclax 400 for acute myeloid leukemia.
Treatment: Venetoclax 400 — The standard treatment for patients with acute myeloid leukemia (AML) with an abnormality in the IDH1 gene, who are not eligible for intensive chemotherapy, is a combination of ivosidenib and azacitidine. In this study it is investigated whether adding venetoclax to the standard treatment can improve the outcome of the treatment of this specific form of AML. The safety is investigated and how well it works. In order to properly assess the value of venetoclax, the effect of venetoclax is compared with the effect of a placebo. A placebo is a product without an active ingredient, a 'fake medicinal product'.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: IDH1 mutation
Patient with newly diagnosed IDH1-mutated AML, or IDH1-mutated MDS/AML... Central confirmation of IDH1 mutation in one of the dedicated central genetic laboratories.
Excluded: PML fusion
Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations / fusion genes
Excluded: RARA fusion
Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations / fusion genes
Excluded: BCR fusion
AML with BCR-ABL1
Excluded: ABL1 fusion
AML with BCR-ABL1
Allowed: IDH2 mutation
Patients with AML with both IDH1 and IDH2 mutation are eligible as well.
Allowed: NPM1 mutation
in case both NPM1 and IDH1 are mutated and both EVOLVE-1... and EVOLVE-2... are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: hypomethylating agent
Exception: for MDS-EB
prior treatment with a hypomethylating agent for MDS-EB is not allowed
Lab requirements
Blood counts
WBC count < 25 x 10^9/L (hydroxyurea allowed to reduce WBC count prior to enrollment)
Kidney function
Serum creatinine ≤ 2.0 × ULN or creatinine clearance >30 mL/min based on Cockcroft-Gault; creatinine clearance ≥ 30 mL/min to <45 mL/min allowed as comorbidity for ineligibility for intensive chemotherapy.
Liver function
Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease or leukemic involvement; AST, ALT, ALP ≤ 3.0 × ULN unless considered due to leukemic involvement; moderate hepatic impairment with total bilirubin > 1.5 to < 3.0 × ULN allowed as comorbidity for ineligibility for intensive chemotherapy.
Cardiac function
No significant active cardiac disease within 3 months prior to start of study treatment (NYHA class III/IV CHF, MI, unstable angina, severe arrhythmias, congenital long QT syndrome, QTcF >480 msec, familial history of sudden death or polymorphic ventricular arrhythmia)
Adequate renal function as evidenced by serum creatinine ≤ 2.0 × ULN or creatinine clearance >30 mL/min... Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement. AST, ALT, ALP ≤ 3.0 × ULN unless considered due to leukemic involvement. WBC count < 25 x 10^9/L. Cardiac: see exclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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