Actively Recruiting

Phase 2
Age: 14Years - 75Years
All Genders
NCT06928376

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

Led by Chinese PLA General Hospital · Updated on 2026-05-08

160

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

Sponsors

C

Chinese PLA General Hospital

Lead Sponsor

F

First Affiliated Hospital of Harbin Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to compare the efficacy and safety of venetoclax combined with the CACAG regimen with the traditional "3+7" regimen in the treatment of newly diagnosed intermediate- or high-risk acute myeloid leukemia (AML).

CONDITIONS

Official Title

A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients

Who Can Participate

Age: 14Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to 75 years, any gender
  • Newly diagnosed with intermediate- or high-risk acute myeloid leukemia (excluding M3 subtype)
  • Liver function with ALT and AST 4 2.5 times the upper limit of normal; bilirubin 4 2 times the upper limit of normal
  • Kidney function with creatinine at or below the upper limit of normal
  • No uncontrolled infections, organ dysfunction, or severe mental illness
  • ECOG performance status score between 0 and 2
  • Predicted survival of at least 4 months
  • No severe allergies
Not Eligible

You will not qualify if you...

  • Allergy or contraindication to any study drug
  • Pregnant or breastfeeding women
  • Known history of alcohol or drug addiction
  • Mental illness or conditions preventing compliance with the study
  • Less than 6 weeks since major organ surgery
  • Liver function with ALT and AST above 2.5 times the upper limit of normal; bilirubin above 2 times the upper limit of normal
  • Kidney function with creatinine above the upper limit of normal
  • Considered unsuitable for the clinical trial due to poor compliance or substance abuse

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

Chinese PLA General Hospital

Beijing, Beijing Municipality, China, 100853

Actively Recruiting

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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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A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients | DecenTrialz