NCT05676697终止1 期
Safety and Efficacy Study of PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy
Institute of Hematology & Blood Diseases Hospital, China2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年1月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Overall response rate
研究概览
简要总结
This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.
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
- •Diagnosis of primary warm antibody hemolytic anemia (AIHA).
- •Hemoglobin < 100g/L
- •Refractory to or relapsed after at least 2 prior treatment line.
- •ECOG performance status ≤ 2
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •Neutrophils counts < 0.5×10^9/L or platelet counts < 50 x 10^9/L
- •Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
- •Diagnosis of the active stage of the connective tissue or systemic autoimmune rheumatic diseases (SARDs)
- •History of lymphoproliferative neoplasms
- •Had other inherited or acquired hemolytic diseases.
- •Secondary AIHA caused by drugs or infection
- •Previously received organ or stem cell transplantation.
- •Had malignant tumor within 5 years before enrollment, exclusive of cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial tumor, cervical carcinoma in situ or other indolent tumors
- •Patients with HBV, HCV, HIV or other infections that require treatment.
- •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.
- •Received rituximab in 6 weeks before enrollment.
- •Received attenuated vaccine 4 in weeks before enrollment
- •Participation in another clinical trial within 4 weeks before the start of this trial
- •Have an allergy to Linperlisib or any other part of this medicine.
- •Previously treated with other PI3Kδ inhibitor.
- •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
PI3K Delta Inhibitor
Experimental
干预措施: Linperlisib (Drug)
结局指标
主要结局
Overall response rate
时间窗: 6-12 weeks
Percentage of patients with hematological response. Hematological response is evaluated by hemoglobin and other hemolysis-related laboratory indicators.
次要结局
- Incidence of the adverse event(12 weeks)
- Complete response rate(6-12 weeks)
- Complete response with incomplete hemolysis recovery, CRi(6-12 weeks)
- Mean change from baseline in hemoglobin (Hgb) levels(6-12 weeks)
- Time to achieve partial response (PR)(6-12 weeks)
- Time to achieve complete response (CR)(6-12 weeks)
- Change of the health-related quality of life(Baseline and 12 weeks)
研究者
Jun Shi
Director of Regenerative Medical Center
Institute of Hematology & Blood Diseases Hospital, China
研究点 (2)
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