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OncoMatch/Clinical Trials/NCT06557421

De-Escalation Study Evaluating Venetoclax and Azacitidine Discontinuation in AML Responding Patients

Is NCT06557421 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Venetoclax and Azacitidine for acute myeloid leukemia.

Phase 2RecruitingInstitut Paoli-CalmettesNCT06557421Data as of May 2026

Treatment: Venetoclax · AzacitidineThe goal of this clinical trial is to test efficacy and safety of a VENETOCLAX-AZACITIDINE (VEN-AZA) de-escalation strategy in Acute Myeloid Leukemia responding patients. The main objectives of the study are: * Evaluation of the efficacy of VEN-AZA de-escalation strategy by measuring the effect of VEN-AZA discontinuation in term of Disease-Free Survival. * Evaluation of the other efficacy parameters and safety of VEN-AZA de-escalation strategy. Patients from the prospective study will be compared to a retrospective cohort of patients who will be selected on the basis of identical eligibility criteria. Participants will: * Stop VEN-DASA treatment * Be closely monitored by regular evaluation of the disease

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

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

Must have received: venetoclax and azacitidine (venetoclax, azacitidine) — first-line

VEN-AZA given as first-line treatment; Duration of VEN-AZA therapy of 12 months (+/- 28 days), regardless of duration of VEN-AZA cycles and the doses

Cannot have received: venetoclax and azacitidine (venetoclax, azacitidine)

VEN-AZA given as salvage therapy

Cannot have received: allogeneic stem cell transplant

Prior allogeneic stem cell transplant

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

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