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

Soochow University

Status and phase: Enrolling; Phase 2

Conditions: Adult T-cell Leukemia/Lymphoma

Treatments: Drug: vindesine; Drug: Chidamide; Drug: Dexamethasone; Drug: Azacitidine (AZA); Drug: VEN (Venetoclax)

Study type: Interventional

Funder types: Other

Identifiers

NCT07159620

2025662

Details and patient eligibility

About

ETP-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) .

Enrollment: 27 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: >14 to 65 years (inclusive).

2. Diagnosis: Patients diagnosed with ETP-ALL like disease meeting the following flow cytometry immunophenotypic criteria:

   ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate ≤75%, and positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.

   Near-ETP-ALL: CD7+, CD1a-, CD8-, CD5 positivity rate >75%, AND positive for at least one myeloid/stem cell antigen marker (including but not limited to CD34, CD117, HLA-DR, CD13, CD33, CD11b, or CD65); MPO negative.

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

3. Newly diagnosed patients who have not received any prior induction therapy before enrollment (excluding hydroxyurea, dexamethasone, low-dose cytarabine, venetoclax with a cumulative dose <0.5g, and leukapheresis).

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

5. Expected survival >6 months.

6. Demonstrated capacity to understand the study and willingness to provide informed consent.

Exclusion criteria

1. Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential

2. Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.

3. Severe Organ Dysfunction:

   Cardiac Insufficiency: Left ventricular ejection fraction (LVEF) ≤40%, OR history of congestive heart failure, unstable coronary artery disease, or severe arrhythmia.

   Respiratory Failure: Partial pressure of arterial oxygen (PaO₂) ≤60 mmHg. Hepatic Impairment: Total bilirubin ≥2 times the upper limit of normal (ULN), OR alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times ULN.

   Renal Impairment: Serum creatinine ≥2 mg/dL, OR creatinine clearance ≤30 mL/min/1.73m².

   Hypersensitivity: History of hypersensitivity to any of the study drugs or compounds of similar chemical structure.

4. Presence of central nervous system (CNS) leukemia.

5. Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Venetoclax Combined with Azacitidine, Chidamide, Vindesine, and Dexamethasone

Experimental group

Description:

Induction Therapy Phase: VACVP induction:Venetoclax: 100mg, d1, 200mg, d2, 400mg, d3-d21, orally. Azacitidine,75mg/m²/day, d1-d7, subcutaneously. Chidamide,10mg, d1-d7, orally. Vindesine, 4mg, d1, intravenous infusion. Dexamethasone,9mg/m²/day, d1-d14; reduced by half on d15-d17; further reduced by half on d18-d21, intravenous infusion or orally. Consolidation therapy: 1. alternate use of HD-MTX-Ara C and VACVP 2. allogeneic hematopoietic stem cell transplantation (HSCT)

Treatment:

Drug: Dexamethasone

Drug: Azacitidine (AZA)

Drug: VEN (Venetoclax)

Drug: Chidamide

Drug: vindesine