Actively Recruiting

Phase 2
Age: 14Years - 65Years
All Genders
NCT07159620

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-09-08

27

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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) .

CONDITIONS

Official Title

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

Who Can Participate

Age: 14Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 14 and 65 years inclusive
  • Diagnosed with ETP-ALL like disease meeting specific flow cytometry criteria for ETP-ALL, near-ETP-ALL, or T-ALL with myeloid mutations
  • Newly diagnosed patients with no prior induction therapy except limited allowed treatments
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
  • Expected survival of more than 6 months
  • Able to understand the study and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy, breastfeeding, or unwillingness to use contraception in women of childbearing potential
  • Uncontrolled active infection including bacterial, fungal, or viral infections; active HBV, HCV, or HIV infection
  • Severe organ dysfunction including cardiac insufficiency (LVEF ≤40%, heart failure, unstable coronary artery disease, severe arrhythmia), respiratory failure (PaO2 ≤60 mmHg), liver impairment (total bilirubin ≥2x ULN or ALT/AST ≥3x ULN), renal impairment (serum creatinine ≥2 mg/dL or creatinine clearance ≤30 mL/min/1.73m2)
  • History of hypersensitivity to any study drug or similar compounds
  • Presence of central nervous system leukemia
  • Any other condition making participation unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

Y

Yang Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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