Menu
Recruiting NCT07159620

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

Phase II Interventional Adult T-cell Leukemia/Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VEN (Venetoclax), Azacitidine (AZA), Chidamide, vindesine.
Who it may be relevant to
Registry conditions: Adult T-cell Leukemia/Lymphoma. Basic parameters: 14 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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) .

Interventions

  • Drug VEN (Venetoclax)
    Orally
  • Drug Azacitidine (AZA)
    Subcutaneous injection
  • Drug Chidamide
    Orally
  • Drug vindesine
    intravenous infusion
  • Drug Dexamethasone
    intravenous infusion or orally

Primary outcome measures

  • Composite Complete Remission Rate（CRc） after induction therapy [Time frame: Time from the completion of induction and before consolidation therapy（up to 42 days）]
Secondary outcome measures (5)
  • Overall survival（OS） [Time frame: 2 years]
  • Relapse-Free Survival(RFS) [Time frame: 2 years]
  • duration of remission (DOR) [Time frame: 2 years]
  • AE [Time frame: Within 30 days after the last chemotherapy]
  • MRD [Time frame: At the end of induction（up to 42 days）, 1 cycle of consolidation（up to 42 days）, 2 cycle of consolidation （up to 42 days）and the end of consolidation（up to 42 days）]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07159620 · 2025662

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗