Actively Recruiting

Phase 2
Age: 14Years +
All Genders
NCT07012447

Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations

Led by yuejun Liu · Updated on 2025-06-10

32

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the efficacy and safety of venetoclax combined with azacitidine in treating newly diagnosed early T-cell precursor (ETP)-like acute lymphoblastic leukemia (ALL), T-ALL with myeloid mutations, or T/myeloid mixed-phenotype acute leukemia (T/My-MPAL). Participant population: Patients aged ≥14 years diagnosed with ETP-like leukemia, T-ALL with myeloid mutations, or T/My-MPAL, regardless of sex/gender. The main question it aims to answer: Does venetoclax plus azacitidine achieve a significantly higher overall response rate (ORR: CR + CRi) compared to historical controls (54% vs. 90%) after two induction cycles? Comparison group: Researchers will compare ORR outcomes to historical data from conventional chemotherapy regimens to assess treatment superiority. Participants will: * Receive two 28-day cycles of venetoclax (oral, 100 mg D1, 200 mg D2, 400 mg D3-28) and azacitidine (75 mg/m²/day SC, D1-7). * Undergo serial bone marrow biopsies, blood tests, and imaging (e.g., PET-CT) for response assessment. * Follow dose adjustment protocols for toxicity management (e.g., neutropenia, thrombocytopenia).

CONDITIONS

Official Title

Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No gender restrictions
  • Age 14 years or older
  • Confirmed diagnosis of ETP-like leukemia, T-ALL with myeloid mutations, or T/myeloid mixed phenotype acute leukemia
  • Newly diagnosed without prior induction therapy (limited prior therapy such as hydroxyurea, dexamethasone, or low-dose cytarabine/venetoclax under 0.5g allowed)
  • Expected survival of at least 3 months
  • Liver function with total bilirubin ≤ 2 times upper limit of normal (ULN); ALT/AST ≤ 3 times ULN (or ≤ 5 times ULN if liver infiltration by leukemia)
  • Kidney function with creatinine clearance ≥ 30 ml/min
  • Heart function with left ventricular ejection fraction over 45%
  • Ability to understand the study and provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of recurrent genetic abnormalities like t(8;21), t(15;17), inv(16)/t(16;16) leukemia
  • Allergy or hypersensitivity to study drugs or similar compounds
  • Active uncontrolled infections
  • Active bleeding
  • History within 1 year of thrombosis, embolism, or brain hemorrhage
  • Pregnancy, breastfeeding, or unwillingness to use contraception if applicable
  • Drug addiction or chronic alcoholism interfering with study evaluation
  • Psychiatric or other conditions preventing informed consent or study compliance
  • Any condition judged by the investigator as unsuitable for participation

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

Ethical Committee of the First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

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Research Team

Y

Yue-jun Liu

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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