Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
Recruiting
Phase 2Interventional Study
Adult T-cell Leukemia/Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
27 (estimated)
Sponsor
The First Affiliated Hospital of Soochow University · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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) .
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 mark…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.