NCT07318662进行中（未招募）不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Venetoclax+HMAs
treatment group, the intervention is the use of Venetoclax(400mg，QD, 1-14d)
干预措施: Venetoclax (Drug)
结局指标
主要结局
overall response rate
时间窗: After the first cycles treatment（Day1, Month2)
CR+mCR+PR+HI
次要结局
- 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)
研究者
Du Xin
professor of medical science
Guangdong Provincial People's Hospital
研究点 (1)
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