Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06737523

Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-24

30

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).

CONDITIONS

Official Title

Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of acute myeloid leukemia (AML) that is relapsed or refractory
  • Age 18 years or older, male or female
  • Expected survival longer than 3 months
  • Creatinine clearance of 50 mL/min or higher
  • Liver enzymes (AST and ALT) less than or equal to 3 times the upper limit of normal, unless due to leukemia involvement
  • Bilirubin less than or equal to 3 times the upper limit of normal, unless due to leukemia involvement
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Not pregnant and using contraception during treatment
  • Able to understand and willing to give informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia (APL)
  • Active central nervous system leukemia
  • Significant heart problems such as prolonged QTc interval (males >450 ms, females >470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, recent heart attack or congestive heart failure within the past year, or symptomatic coronary heart disease requiring medication
  • Active, uncontrolled severe infection
  • Other non-myeloid cancers within the past 2 years
  • Mental health disorders that prevent participation
  • Previous solid organ transplant (except stem cell transplant if no graft-versus-host disease or immunosuppressive treatment ongoing)
  • Any other condition that the investigator believes makes participation unsuitable

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 Xiamen University

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

B

Bing 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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