NCT05676710已完成1 期
A Single-arm, Open-label, Pilot Study on the Efficacy and Safety of PI3K Inhibitors in Relapsed/Refractory Large Granular T Lymphocytic Leukemia
Institute of Hematology & Blood Diseases Hospital, China2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年2月10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
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Overall response rate: HPR + HCR + CMR
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 patients with relapsed/refractory large granular T lymphocytic leukemia.
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 T-cell large granular lymphocytic leukemia (T-LGLL)
- •Meet any of the following indications for treatment：
- •Hemoglobin < 100g/L or RBC transfusion dependence
- •Neutrophil count <0.5×10^9/L or neutrophil count decreased with recurrent infection
- •Progressive splenomegaly and/or Massive Splenomegaly
- •Combined with autoimmune diseases requiring treatment, such as rheumatoid arthritis, autoimmune thyroiditis, etc.
- •Severe B symptoms
- •Failure or intolerance to a first-line therapy
- •ECOG performance status ≤2
- •Expected survival ≥ 6 months
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •History of other lymphoproliferative neoplasms
- •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
- •Previously received organ or stem cell transplantation.
- •Patients with active infection within 2 weeks before giving the first dose of medication
- •Patients with HBV, HCV, HIV or other infections that require treatment
- •History of immunodeficiency, or congenital immunodeficiency disorders
- •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.
- •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
- •History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.
- •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
Experimental
Experimental
PI3K inhibitors
干预措施: Linperlisib (Drug)
结局指标
主要结局
Overall response rate: HPR + HCR + CMR
时间窗: 8 weeks
Percentage of patients with hematological response. Hematological response is evaluated by hemoglobin (Hb), absolute neutrophil count (ANC), platelet count (PLT), absolute lymphocyte count (ALC), absolute large granular lymphocyte count, and blood transfusion.
次要结局
- Incidence of the adverse event(8 weeks)
- Time to achieve partial hematologic response (HPR)(8 weeks)
- Time to achieve complete hematologic response (HCR)(8 weeks)
- Change of the health-related quality of life(Baseline and 2 cycles of therapy)
- Relapse free survival (RFS)(A minimum of 2 years of planned follow-up)
- Time to achieve complete molecular response (CMR)(8 weeks)
研究者
研究点 (2)
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