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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax+HMAs | treatment group, the intervention is the use of Venetoclax(400mg,QD, 1-14d) |
| |
| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate | CR+mCR+PR+HI | After the first cycles treatment(Day1, Month2) |
| Measure | Description | Time Frame |
|---|---|---|
| IWG2023 Composite response rate | CR+CR-L+CRh+CRequ | After the first cycles treatment(Day1, Month2 ) |
| overall survival | Refers to the time from the start of treatment to the patient's death or last follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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| through study completion, an average of 1 year |
| Blood transfusion dependence | Change in proportion of transfusion dependence from the start of treatment | through study completion, an average of 1 year |
| adaverse event rate | Grade 3-4 adverse events | Up to 1 years after the last subject enrolled. |