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OncoMatch/Clinical Trials/NCT07159620

Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

Is NCT07159620 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for adult t-cell leukemia/lymphoma.

Phase 2RecruitingThe First Affiliated Hospital of Soochow UniversityNCT07159620Data as of May 2026

Treatment: VEN (Venetoclax) · Azacitidine (AZA) · Chidamide · vindesine · DexamethasoneETP-ALL like patients have poor outcomes and prognosis, and the optimal therapeutic approaches are poorly characterized. The goal of this clinical trial is to evaluate the efficacy and safety of the venetoclax combined with azacitidine, chidamide, vindesine, and dexamethasone regimen in newly diagnosed ETP-ALL like patinets (including ETP-ALL, near ETP-ALL and T-ALL with myeloid mutations) .

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Allowed: FLT3 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: DNMT3A mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: STAG2 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: IDH1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: IDH2 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: RUNX1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: EZH2 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: WT1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: ASXL1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: ASXL2 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: SF3B1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: TET2 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: BCOR mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Allowed: BCORL1 mutation

T-ALL with myeloid mutations: FLT3, DNMT3A, STAG2, IDH1/IDH2, RUNX1, EZH2, WT1, ASXL1/ASXL2, SF3B1, TET2, BCOR, BCORL1

Performance status

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

Prior therapy

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

Lab requirements

Kidney function

Serum creatinine <2 mg/dL, creatinine clearance >30 mL/min/1.73m²

Liver function

Total bilirubin <2 times ULN, ALT and AST <3 times ULN

Cardiac function

LVEF >40%, no history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia

Severe Organ Dysfunction: Cardiac Insufficiency: LVEF ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia. Respiratory Failure: PaO₂ ≤60 mmHg. Hepatic Impairment: Total bilirubin ≥2 times ULN, OR ALT or AST ≥3 times ULN. Renal Impairment: Serum creatinine ≥2 mg/dL, OR creatinine clearance ≤30 mL/min/1.73m².

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

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