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OncoMatch/Clinical Trials/NCT06536959

VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

Is NCT06536959 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine for relapsed acute myeloid leukemia.

Phase 2RecruitingBeijing 302 HospitalNCT06536959Data as of May 2026

Treatment: PD-1 inhibitor, Venetoclax, Decitabine, AzacytidineThe efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

Min 1 prior line

Must have received: induction chemotherapy

Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy

Cannot have received: major surgery

Major surgery...within 2 weeks of the first medication

Cannot have received: radiotherapy

radiotherapy...within 2 weeks of the first medication

Cannot have received: chemotherapy

chemotherapy...within 2 weeks of the first medication

Cannot have received: biological therapy

biological therapy...within 2 weeks of the first medication

Cannot have received: immunotherapy

immunotherapy...within 2 weeks of the first medication

Cannot have received: experimental therapy

experimental therapy...within 2 weeks of the first medication

Lab requirements

Kidney function

creatinine≤2×uln

Liver function

alt and ast ≤2×uln; bilirubin≤2×uln

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

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