Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06386302

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-03

184

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.

CONDITIONS

Official Title

Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Diagnosed with AML (non-M3) according to WHO 2016 standards
  • No previous treatment for AML
  • Not eligible for intensive chemotherapy due to age (75 years or older) or age 18 to 74 with specific comorbidities such as ECOG performance status 2 or 3, certain heart diseases, lung function limitations, kidney function between 30 to less than 45 mL/min clearance, moderate liver impairment, or other comorbidities judged by physician
  • ECOG performance status 0 to 2 if aged 75 or older, or 0 to 3 if aged 18 to 74
  • Expected survival time of 3 months or more
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Having other malignant tumors
  • Previous treatment with chidamide, venetoclax, or azacitidine
  • Low-risk AML per NCCN 2022 guidelines with specific genetic markers
  • AML infiltration in the central nervous system
  • Cardiac angioplasty or stent placement within 12 months, history of myocardial infarction, unstable angina, or significant heart disease
  • Active infections or uncontrolled organ bleeding
  • Pregnant or lactating women
  • Participation in other clinical trials within 3 months prior to consent
  • Any condition deemed unsuitable for study participation by the researcher

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

Blood Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

J

Jianxiang Wang, Medical PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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