Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in ND Int-and H-risk MDS or CMML

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT07318662
Status
Active Not Recruiting

Conditions

  • CMML
  • MDS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Previous phase Ib studies have fully demonstrated that venetoclax combined with HMAs is well tolerated in patients with MDS or CMML. Patients treated with VEN/AZA had a higher chance of SCT after remission and a higher survival benefit

Study Details

The aim of this study is to observe and analyze the clinical efficacy of Venetoclax+HMAs regimen in the treatment of newly diagnosed higher-risk MDS and CMML cases, and to compare the efficacy of venetoclax +HMAs regimen with that of HMAS regimen alone, in order to provide a normative scheme and basis for clinical use.

Key Dates

Start date
Jan 1, 2020
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
224 participants (estimated)

Arms

  • Arm: Venetoclax+HMAs
    treatment group, the intervention is the use of Venetoclax(400mg，QD, 1-14d)
  • Arm: Standard treatment(HMAs)
    The control group，Azacitidine（75mg/m2 ，QD, sc，d1-d7）or Decitabine（15mg/m2, q8h-q12h, d1-d3 or 20mg/m2,qd, d1-d5)

Primary Outcome Measure

overall response rate [ Time Frame: After the first cycles treatment（Day1, Month2) ]

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