Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05305859

Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-09-11

30

Participants Needed

1

Research Sites

285 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Xiamen University

Lead Sponsor

F

Fujian Provincial Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML

CONDITIONS

Official Title

Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with relapsed or refractory acute myeloid leukemia confirmed by morphology and immunology
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of at least 3 months
  • Adequate kidney function with creatinine clearance of 30 mL/min or higher and serum creatinine 160 µmol/L or lower
  • Liver enzymes ALT and AST at or below 3 times the upper limit of normal
  • Able to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia (APL)
  • Presence of central nervous system leukemia
  • Uncontrolled or significant cardiovascular diseases including severe bradycardia, long QT syndrome, high blood pressure above specified limits, serious ventricular arrhythmias, certain heart blocks without pacemakers, recent heart attacks, advanced heart failure, complete left bundle branch block, or low left ventricular ejection fraction
  • Active acute or chronic systemic fungal, bacterial, or viral infection not controlled by treatment
  • History of other non-myeloid cancers within 2 years except certain treated skin or in-situ cancers or other solid tumors with no evidence of disease
  • Females who are pregnant or breastfeeding
  • Mental disorders that interfere with participation
  • Previous solid organ transplantation with ongoing graft-versus-host disease or immunosuppression
  • Any other condition deemed by the investigator to prevent safe participation in the trial

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

Bing Xu

Xiamen, Fujian, China, 361003

Actively Recruiting

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Research Team

B

Bing Xu, M.D.

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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