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

NCT07318662 | Active Not Recruiting

• 1 other identifier: GDPH-2024-MDS-1.2
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

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

Keywords

MDS; CMML; Venetoclax; Hypomethylating agents

Outcome Measures

Primary Outcomes (1)

• overall response rate

  CR+mCR+PR+HI

  After the first cycles treatment（Day1, Month2)

Secondary Outcomes (4)

• IWG2023 Composite response rate

  After the first cycles treatment（Day1, Month2 )

• overall survival

  through study completion, an average of 1 year

• Blood transfusion dependence

  through study completion, an average of 1 year

• adaverse event rate

  Up to 1 years after the last subject enrolled.

Study Arms (2)

Venetoclax+HMAs

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

Drug: Venetoclax

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)

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

Venetoclax+HMAs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged 18 years or older with newly diagnosed myelodysplastic agenda syndrome (MDS)and chronic myelomonocytic leukemia (CMML)according to the 2016WHO or 2022 WHO criteria

You may qualify if:

• Age ≥18 years old, male or female;
• MDS or CMML diagnosed by the 2016 or 222 WHO criteria, with a sustained survival of at least 12 weeks;
• 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.) ;
• bone marrow blast cell count (BM blast \> 5%) or IPSS-R score \> 3 (intermediate risk, high risk, very high risk);
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• complete case information could be obtained.

You may not qualify if:

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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

venetoclax

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medical science

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)