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

NCT ID: NCT07318662

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2027-03-30

Brief Summary

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.

Conditions

MDS; CMML

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Venetoclax+HMAs

treatment group, the intervention is the use of Venetoclax(400mg，QD, 1-14d)

Venetoclax

Intervention Type: 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

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)

No interventions assigned to this group

Interventions

Venetoclax

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, male or female;

2. MDS or CMML diagnosed by the 2016 or 222 WHO criteria, with a sustained survival of at least 12 weeks;

3. received more than two cycles of Venetoclax plus HMAs or HMAs alone without prior disease specific or allogeneic hematopoietic stem cell therapy (before initiating Venetoclax or HMAs, Medications such as hydroxyurea were allowed to reduce the white-cell count to 1.0×109 per liter or less.) ;

4. bone marrow blast cell count (BM blast > 5%) or IPSS-R score > 3 (intermediate risk, high risk, very high risk);

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2;

6. complete case information could be obtained.

2. inability to obtain complete case information or to follow protocol steps or follow up on time;

3. other conditions considered by the investigators to be unsuitable for inclusion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Du Xin

professor of medical science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GDPH-2024-MDS-1.2

Identifier Type: -

Identifier Source: org_study_id