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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age: \>14 to 75 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 it's running

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

Study contacts

• Study coordinator: Yang Xu
• Email: xuyang1020@126.com
• Phone: 86+051267781850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.