Status:
RECRUITING
Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Adult T-cell Leukemia/Lymphoma
Eligibility:
All Genders
14-65 years
Phase:
PHASE2
Brief Summary
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 v...
Eligibility Criteria
Inclusion
- Age: \>14 to 65 years (inclusive).
- 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.
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival \>6 months.
- Demonstrated capacity to understand the study and willingness to provide informed consent.
Exclusion
- Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
- Presence of uncontrolled active infection (including bacterial, fungal, or viral infections); concurrent active HBV, HCV, or HIV infection.
- 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.
- Presence of central nervous system (CNS) leukemia.
- Any other condition deemed by the investigator to make the subject unsuitable for participation in this trial.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT07159620
Start Date
September 1 2025
End Date
September 1 2030
Last Update
September 8 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000