eligibility_summary
Inclusion: Relapsed/refractory AML or MDS needing chemo, failure/recurrence or residual disease after 1 induction, consent, recovered prior toxicities, ECOG 0–3, adequate organs (ALT/AST/Cr/Bili ≤2×ULN), Karnofsky ≥70, life expectancy ≥12 wks, not pregnant/breastfeeding. Exclusion: other active malignancy ≤2 yrs, therapy ≤2 wks, serious/uncontrolled disease (e.g., CHF III/IV, MI <6 mo, uncontrolled HTN/infection, CKD), noncompliance, concurrent anti-cancer drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm study in relapsed/refractory AML or high-risk MDS testing a triple regimen: 1) PD-1 inhibitor (tislelizumab), a monoclonal antibody immune-checkpoint inhibitor that blocks PD-1 on T cells to restore anti-leukemia immunity, 2) venetoclax, an oral small-molecule BCL-2 (BH3-mimetic) inhibitor that triggers mitochondrial apoptosis in leukemic blasts, 3) a hypomethylating agent—decitabine or azacitidine—nucleoside analog DNMT inhibitors that induce DNA hypomethylation, reactivate silenced genes, and can enhance antigen presentation. Targeted cells/pathways: PD-1/PD-L1 axis on T cells and tumor cells, BCL-2–dependent AML/MDS blasts (intrinsic apoptosis pathway), and epigenetic dysregulation via DNA methylation in malignant myeloid clones/MRD.