Venetoclax with azacitidine, chidamide, vindesine, and dexamethasone for newly diagnosed ETP-ALL–like leukemia

A Prospective Single-Arm Clinical Study of Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients

This test tries a five-drug combination including venetoclax and azacitidine in adults 14–65 with newly diagnosed ETP-ALL–like leukemia to see if it improves remission rates and side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07159620 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, single-center interventional trial of a combination regimen (venetoclax, azacitidine, chidamide, vindesine, and dexamethasone) given as induction therapy for newly diagnosed ETP-ALL–like patients. Eligible patients include those with ETP-ALL, near‑ETP‑ALL, or T‑ALL with specified myeloid mutations, and who have not received prior induction therapy. The trial will monitor treatment responses, remission rates, and safety/tolerability during and after induction. Outcomes will inform whether this multi-agent approach produces deeper or more durable remissions in this high-risk population.

Who should consider this trial

Good fit: Adults aged >14 to 65 with newly diagnosed ETP-ALL, near‑ETP‑ALL, or T‑ALL with the listed myeloid mutations who have not received prior induction therapy are ideal candidates.

Not a fit: Patients older than 65, those who have already received standard induction chemotherapy, patients with MPO‑positive leukemia, or individuals with major comorbidities may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the regimen could raise remission rates and improve outcomes for patients with ETP-ALL–like disease who currently have poor prognoses.

How similar studies have performed: Combinations of venetoclax with hypomethylating agents have shown promising activity in myeloid malignancies and occasional lymphoid cases, but using venetoclax plus chidamide and vindesine specifically for ETP-ALL–like disease is largely novel.

Eligibility criteria

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Yang Xu

Conditions Adult T-cell Leukemia/Lymphoma