NCT05925504招募中2 期
Safety and Efficacy Study of the Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年7月1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
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving hematologic improvement - erythroids (HI-E) according to IWG 2006 criteria
研究概览
简要总结
This is a prospective, single center, single-arm, phase 2 study. The aim of this study is to evaluate the efficacy and safety of Luspatercept for Patients with Lower-risk Myelodysplastic Syndromes (MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female age ≥ 18 years
- •Subject has diagnosis of MDS according to WHO classification that meets IPSS-R score ≤3.5
- •Hemoglobin < 100g/L at baseline
- •Refractory or intolerant to prior ESA treatment or EPO≥500U/L
- •ECOG performance status ≤2
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •Platelet counts < 50 x 10^9/L
- •Previously treated with either luspatercept or sotatercept
- •Use any of the following prior to this study
- •Immunomodulatory drugs such as lenalidomide [IMiD] for ≥4 weeks
- •Immunosuppressive therapy [IST] for ≥4 weeks
- •Demethylating agents [HMA] ≥ 1 cycle of treatment
- •MDS associated with del 5q cytogenetic abnormality
- •Secondary MDS, i.e. MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
- •Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding.
- •Prior allogeneic or autologous stem cell transplant.
- •Prior history of malignancies, other than MDS, unless the subject is free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥ 5 years. However, subjects with the following history/concurrent conditions are allowed: basal or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasia, carcinoma in situ of the cervix or other indolent tumors.
- •Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.
- •Clinically significant cardiac disease, including any of the follow: uncontrolled angina pectoris, myocardial infarction, unstable cardiac arrhythmias, congestive heart failure and New York Heart Association (NYHA) grade 2-4 cardiac failure.
- •Abnormal liver function: two consecutive examinations with an interval of ≥1 week suggest that ALT and AST are 2.5 times higher than the upper limit of normal values
- •Renal impairment: creatinine clearance <60ml/min
- •Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study, including clinically significant cardiac diseases, refractory hypertension, metabolic disorders and other diseases that seriously affect the function of the gastrointestinal tract.
- •Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
- •Major surgery within 8 weeks prior to this study. Subjects must be completely recovered from any previous surgery prior to this study.
- •Received attenuated vaccine in 4 weeks before enrollment.
- •Participation in another clinical trial within 4 weeks before the start of this trial.
- •History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the luspatercept.
- •Pregnant or breast-feeding patients
- •Patients considered to be ineligible for the study by the investigator for reasons other than the above.
研究组 & 干预措施
Luspatercept
Experimental
open-label, single-arm
干预措施: Luspatercept (Drug)
结局指标
主要结局
Proportion of subjects achieving hematologic improvement - erythroids (HI-E) according to IWG 2006 criteria
时间窗: within 12 weeks
次要结局
- Proportion of subjects achieving RBC-TI according to IWG 2006 criteria(within 12 weeks)
- Mean change in serum ferritin(within 12 weeks)
- Median time to HI-E or RBC-TI(within 12 weeks)
- Incidence of the adverse event(within 12 weeks)
研究者
Gao Zhen
Physician of Regenerative Medical Center
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
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