NCT07318662
Active, not recruiting
Not Applicable
Efficacy and Safety of HMAs Combined With Venetoclax Versus HMAs Alone in Newly Diagnosed Patients With Intermediate-/High-Risk MDS and CMML : A Retro-prospective, Multicenter Observational Cohort Study
Guangdong Provincial People's Hospital1 site in 1 country224 target enrollmentStarted: January 1, 2020Last updated:
InterventionsVenetoclax
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- overall response rate
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •patients who did not meet the inclusion criteria;
- •inability to obtain complete case information or to follow protocol steps or follow up on time;
- •other conditions considered by the investigators to be unsuitable for inclusion.
Arms & Interventions
Venetoclax+HMAs
treatment group, the intervention is the use of Venetoclax(400mg，QD, 1-14d)
Intervention: Venetoclax (Drug)
Outcomes
Primary Outcomes
overall response rate
Time Frame: After the first cycles treatment（Day1, Month2)
CR+mCR+PR+HI
Secondary Outcomes
- Blood transfusion dependence(through study completion, an average of 1 year)
- adaverse event rate(Up to 1 years after the last subject enrolled.)
- IWG2023 Composite response rate(After the first cycles treatment（Day1, Month2 ))
- overall survival(through study completion, an average of 1 year)
Investigators
Du Xin
professor of medical science
Guangdong Provincial People's Hospital
Study Sites (1)
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