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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 (Jun 2026). This Phase 2 trial studies multiple treatments including Venetoclax and Azacitidine for acute myeloid leukemia.

Phase 2RecruitingInstitut Paoli-CalmettesNCT06557421Data as of Jun 2026Location: France

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

Treatments studied

Targeted therapy

Venetoclax

Chemotherapy

Azacitidine

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.

Frequently asked questions

Is NCT06557421 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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