OncoMatch/Clinical Trials/NCT05431257
Azacitidine in Combination With Low Dose Intensity Venetoclax in Patients With AML Incl. Explorative AML Profiling
Is NCT05431257 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Venetoclax for acute myeloid leukemia.
Treatment: Venetoclax — Multi-center phase II study of standard azacytidine treatment (AZA; D1-D7, 75mg/m2 qd) in combination with a short duration of "low-dose" venetoclax treatment (LD-VEN; D1-D14 before CR and D1-D7 after CR, 400mg qd) per 28 days cycle for elderly/unfit (arm 1) and relapsed/refractory (arm 2) patients with acute myeloid leukemia. AZA and LD-VEN treatment is combined with exploratory AML profiling using established platforms for OMICs analyses and ex vivo drug sensitivity and resistance testing. This will validate the feasibility of AML profiling in a clinical setting to predict responders and non-responders to AZA/LD-VEN therapy. The exploratory AML profiling program will also identify biomarkers as well as novel drugs and drug combinations applicable for treatment of AML patients in future clinical trial initiatives.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
ECOG Performance status ≤ 2 for patients ≥ 75 years of age OR ≤ 3 for patients ≥ 18 to 74 years of age.
Prior therapy
Must have received: cytotoxic chemotherapy — relapsed/refractory AML
Relapsed/refractory AML after at least 1 line of prior therapies
Must have received: hypomethylating agent — refractory AML
Patients who fail to achieve a complete or partial remission after previous monotherapy with HMA or induction chemotherapy (at least 1 cycle of chemotherapy containing cytarabine or clofarabine, in combination with a topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone).
Must have received: induction chemotherapy — refractory AML
Patients who fail to achieve a complete or partial remission after previous monotherapy with HMA or induction chemotherapy (at least 1 cycle of chemotherapy containing cytarabine or clofarabine, in combination with a topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone).
Cannot have received: BCL2 inhibitor (venetoclax)
Prior venetoclax treatment for myeloid malignancy.
Lab requirements
Kidney function
creatinine clearance ≥ 30 mL/min; determined by the Cockcroft Gault formula
Liver function
alanine aminotransferase (ALT) ≤ 4.0 × ULN; bilirubin ≤ 1.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) < 50% (ineligible for intensive chemotherapy); Cardiovascular disability status of New York Heart Association Class ≥ 2 excluded
Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined by the Cockcroft Gault formula. Adequate liver function as demonstrated by alanine aminotransferase (ALT) ≤ 4.0 × ULN; bilirubin ≤ 1.5 × ULN. Left ventricular ejection fraction (LVEF) < 50%. Cardiovascular disability status of New York Heart Association Class ≥ 2.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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