CTRI/2024/06/068588招募中3 期
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) vs Epoetin Alfa for the Treatment of Anemia Due to Revised International Prognostic Scoring System (IPSS-R) Very Low, Low, or Intermediate-Risk Myelodysplastic Syndrome (MDS) in Erythropoiesis-stimulating Agent (ESA)-naive Participants who are Non-Transfusion Dependent (NTD)
Bristol Myers Squibb India Private Limited6 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年7月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- To compare the proportion of participants with lower-risk NTD MDS who convert to TD (≥3 RBC units/16weeks based on IWG 2018)70between luspatercept vs epoetin alfa
研究概览
简要总结
This is a global Phase 3, open-label, randomized multicenter study to compare the efficacy and safety of luspatercept (BMS-986346/ACE-536) versus epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, or intermediate-risk MDS in ESA-naive participants who are NTD. The study for each participant will include a Screening Period of 5 weeks (35 days), a Treatment Period of 96 weeks, an Extension Phase, and a Post Treatment Follow-up Period (PTFP) for approximately 5 years from first dose of the investigational product (IP) or approximately 3 years from last dose (whichever occurs later). The Extension Phase, and/or PTFP may be completed during this study or a rollover protocol for continued access to IP and to evaluate long-term safety of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females ≥ 18 years of age (or local age of consent) at the time of signing the informed consent.
- •Participant has documented diagnosis of MDS according to World Health Organization (WHO) 2016 that meet IPSS-R classification of very low, low, or intermediate-risk disease, (Intermediate-risk of less than 3.5 IPSS-R score) confirmed via bone marrow aspirate and: a) less than 5 percentage blasts in bone marrow and less than 1 percentage blasts in peripheral blood 3) Participant has a baseline endogenous serum erythropoietin level of less than 500 UL.
- •Participant must be transfusion independent, according to IWG 2018 criteria as documented by the following criteria a) Received no RBC transfusions within 16 weeks prior to randomization 5) Participant has a mean baseline Hb concentration prior to randomization of less than or equal to 9.5 g per dL.
- •Mean Hb is defined as the mean of all central or local or pre-transfusion available Hb measurements during the 16 weeks prior to randomization (with a minimum of 2 measurements at least 1 week apart).
- •Only Hb levels greater than 21 days following a transfusion are acceptable.
- •The last measurement must be within 35 days of randomization 6) Participant has symptom(s) of anemia a) Participant records a severity score of moderate or greater on at least 1 PGI-S item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period 7) Participant has Eastern Cooperative Oncology Group score of 0, 1, or 2 8) Participant must be Erythropoiesis-stimulating agent (ESA) Naive.
- •Prior treatment with epoetin alfa or epoetin biosimilars, or darbepoetin alfa, is not acceptable for entry into the study.
排除标准
- •Participant with MDS associated with del (5q) cytogenetic abnormality or MDS unclassifiable (MDS-U) according to WHO 2016 classification 2)Participant with myelodysplastic or myeloproliferative neoplasms (MDS or MPN) according to WHO 2016 classification that is chronic myelomonocytic leukemia, Atypical chronic myeloid leukemia, BCR-ABL12, juvenile myelomonocytic leukemia, MDS or MPN unclassifiable) 3) Participant with secondary MDS (MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and or radiation for other diseases) 4) Participant with known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia (Example- severe G6PD deficiency, pyruvate kinase deficiency, etc), or hypothyroidism, or any type of known clinically significant bleeding or sequestration. Participant with drug induced anemia (Example.
- •mycophenolate). a) Iron deficiency to be determined by serum ferritin less than 100 ug per L and additional testing if clinically indicated (Example.
- •calculated transferrin saturation [iron or total iron binding capacity less than or equal to 20 percentage] or bone marrow aspirate stain for iron). 5)Bleeding disorders manifested by frequent bleeding episodes (Example.
- •menorrhagia, epistaxis, clotting disorders) 6)Participant with known history of diagnosis of acute myeloid leukemia 7)Uncontrolled hypertension defined as repeated elevations of systolic blood pressure of greater than or equal to 140 mmHg and or diastolic blood pressure greater than or equal to 90 mmHg despite adequate treatment or with a history of hypertensive crisis or hypertensive encephalopathy.
结局指标
主要结局
To compare the proportion of participants with lower-risk NTD MDS who convert to TD (≥3 RBC units/16weeks based on IWG 2018)70between luspatercept vs epoetin alfa
时间窗: Week 1 through Week 96
次要结局
- To compare the erythroid response of luspatercept vs epoetin alfa in participants with lower-risk NTD MDS based on IWG 2018(Week 1 through Week 48)
- To further compare the erythroid response with luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Week 1 through Week 48)
- To further compare the proportion of participants with lower-risk NTD MDS who convert to TD (≥3 RBC units/16 weeks based on IWG 201870) between luspatercept vs epoetin alfa(Week 1 through Week 48)
- To evaluate whether luspatercept reduces the risk of conversion to transfusion dependence (TD) in participants with lower-risk NTD MDS based on IWG 2018(Week 1 through EOS)
- Transfusion-free survival
- To further compare the RBC transfusion burden effect of luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Week 1 through Week 48)
- To assess the effect of luspatercept vs epoetin alfa on HRQoL in participants with lower-risk NTD MDS(Screening through 42 days post last dose)
- To characterize the safety and immunogenicity of luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Screening through 42 days post last dose)
- To characterize the PK of luspatercept in participants with lower-risk NTD MDS(W1D1 through Week 96)
- To compare the neutrophil and platelet response with luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Week 1 through Week 24)
- To compare the rates of progression to high-risk MDS and AML with luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Randomization through EOS)
- To compare overall survival with luspatercept vs epoetin alfa in participants with lower-risk NTD MDS(Randomization through EOS)
- Duration of mHI-E(Week 1 through EOT)
- Time to mHI-E(Week 1 through Week 48)
- RBC TI for > 24 weeks(Week 1 through Week 48)
研究者
Shilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
研究点 (6)
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