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OncoMatch/Clinical Trials/NCT05833438

Venetoclax in Combination with 5 Days Azacitidine in Untreated AML Patients, Not Eligible for Standard Induction Therapy

Is NCT05833438 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies VEN+AZA-5 for acute myeloid leukemia (aml).

Phase 2RecruitingUniversity of LeipzigNCT05833438Data as of May 2026

Treatment: VEN+AZA-5Acute myeloid leukemia (AML): continuous oral Venetoclax (VEN) and 7 days of s.c. Azacitidine (AZA) per 28-day cycle = standard of care for intensive induction therapy ineligible AML patients in Germany The VENAZA-5S pilot trial: AZA administration reduced to 5 days within each cycle to improve tolerability and treatment adherence due to less neutropenic infections, less treatment interruptions and less hospitalizations.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: hypomethylating agent

Exception: Prior use of hydroxyurea is allowed

Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following: Hypomethylating agent (HMA)

Cannot have received: chemotherapeutic agent

Exception: Prior use of hydroxyurea is allowed

Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following: Chemotherapeutic agent

Cannot have received: CAR-T cell therapy

Exception: Prior use of hydroxyurea is allowed

Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following: Chimeric Antigen Receptor (CAR)-T cell therapy

Cannot have received: experimental therapies

Exception: Prior use of hydroxyurea is allowed

Prior treatment for AML or myelodysplastic syndrome (MDS) with one of the following: Experimental therapies

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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