NCT05469737进行中（未招募）2 期
A Phase 2/3, Multicenter, Randomized, Dose Optimization (Part I), Double-blind (Part II) Study to Compare the Efficacy and Safety of Oral Azacitidine (Oral-Aza, ONUREG®) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Participants With IPSS-R Low- or Intermediate-risk Myelodysplastic Syndrome (MDS)
Bristol-Myers Squibb118 个研究点 分布在 14 个国家目标入组 230 人开始时间: 2022年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
- 试验地点
- 118
- 主要终点
- Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of oral azacitidine in participants with low to intermediate International Prognostic Scoring System Revised (IPSS-R) myelodysplastic syndrome (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5).
- •MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results.
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
排除标准
- •Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy)
- •Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10%
- •Participants diagnosed with MDS with excess blasts-2 (MDS-EB2)
- •Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part II - Oral-Aza (RP3D)
Experimental
RP3D: Recommended Phase 3 Dose
干预措施: Oral Azacitidine (Drug)
Part I - Oral-Aza (Dose 1)
Experimental
干预措施: Oral Azacitidine (Drug)
Part I - Oral-Aza (Dose 2)
Experimental
干预措施: Oral Azacitidine (Drug)
Part II - Placebo
Experimental
干预措施: Placebo for Oral Azacitidine (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0
时间窗: 6 cycles plus 28 days (up to 24 weeks)
Phase 2
Number of participants who achieved complete remission (CR) per International Working Group (IWG) 2006 criteria within 6 cycles
时间窗: Up to 24 weeks
Phase 2 and 3
次要结局
- CR duration(Over the course of the study, an average of 1 year)
- Number of participants who achieved Overall Response (OR) per IWG 2006 criteria within 6 cycles(Up to 24 weeks)
- PLT-TI duration(Over the course of the study, an average of 1 year)
- pRBC transfusion reduction duration(Over the course of the study, an average of 1 year)
- OR duration(Over the course of the study, an average of 1 year)
- Event-free Survival (EFS)(Up to 5 years after discontinuation of Investigational Product, approximately 6 years)
- Number of participants who achieved 84-day packed red blood cells transfusion independence (pRBC-TI)(Up to 32 weeks)
- Number of participants who achieved pRBC transfusion reduction(Over the course of the study, an average of 1 year)
- Best OR(Over the course of the study, an average of 1 year)
- Time to acute myeloid leukemia (AML)(Up to 5 years after discontinuation of Investigational Product, approximately 6 years)
- Number of participants with Adverse Events (AEs) evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria v.5.0(Up to end of treatment/early termination, an average of 1 year)
- Summary statistics for Quality of Life in Myelodysplasia Scale (QUALMS) scales and subscales at each assessment point for each treatment arm(Up to end of treatment/early termination, an average of 1 year)
- Summary statistics for the EuroQol 5 Dimension 5 Level (EQ-5D-5L) scales and subscales at each assessment point for each treatment arm(Up to end of treatment/early termination, an average of 1 year)
- pRBC-TI duration(Over the course of the study, an average of 1 year)
- Number of participants who achieve 84 day platelet transfusion independence (PLT-TI) within 6 cycles(Over the course of the study, an average of 1 year)
- Number of participants with healthcare resource use associated with the investigational product (IP)(Over the course of the study, an average of 1 year)
- Overall Survival (OS)(Up to 5 years after discontinuation of Investigational Product, approximately 6 years)
- Iron parameters measured from blood(Over the course of the study, an average of 1 year)
- Summary statistics for Functional Assessment of Cancer Therapy-Anemia (FACT-An) scales and subscales at each assessment point for each treatment arm(Up to end of treatment/early termination, an average of 1 year)
- Time to subsequent therapy(Up to 5 years after discontinuation of Investigational Product, approximately 6 years)
研究者
研究点 (118)
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