2023-507153-16-00招募中3 期
A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination with Azacitidine in Patients Newly Diagnosed with Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 54
- 主要终点
- The primary endpoint of this study is Overall Survival.
研究概览
简要总结
To assess the efficacy of venetoclax in combination with azacitidine compared to placebo with azacitidine in treatment-naïve, higher-risk MDS population. The hypothesis corresponding to the primary objective is that venetoclax will improve the overall survival (OS) when added to standard of care azacitidine treatment in patients newly diagnosed with higher-risk MDS.
研究设计
- 分配方式
- Randomized
- 主要目的
- This is a Phase 3, randomized, double-blind, placebo-controlled study
- 盲法
- Double (Monitor, Carer, Analyst, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects must be ≥ 18 years of age with a diagnosis of MDS according to the 2016 World Health Organization (WHO) classification with presence of < 20% bone marrow blasts per marrow biopsy/aspirate at screening.
- •Subjects must have no prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogeneic stem cell transplantation, and must meet the following disease activity criteria: Overall Revised International Prognostic Scoring System (IPSS-R) score > 3 (intermediate, high, or very high); Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2; Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at the time of Study Day 1 (not to exceed approximately 19% of subjects enrolled on study), or HSCT ineligible without plan for HSCT at the time of Study Day 1.
排除标准
- •For further information on the exclusion criteria, please refer to section 5.1 Eligibility Criteria of the Study Protocol
结局指标
主要结局
The primary endpoint of this study is Overall Survival.
The primary endpoint of this study is Overall Survival.
次要结局
- Modified overall response (mOR) defined as complete remission (CR) + partial remission (PR) + marrow CR (mCR)
- Overall hematological improvement (HI) (platelet, neutrophil, or erythroid)
- Complete remission
- Red blood cell (RBC) and platelet transfusion independence for subjects who are transfusion dependent on RBC and/or platelet at baseline
- Time to deterioration in physical functioning, as measured by the physical functioning domain of EORTC QLQ-C30
- Change from baseline in fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue SF 7a
- Overall response (OR) defined as CR + PR
研究者
Global Clinial Trial Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (54)
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