A Umbrella Study in Relapsed/Refractory Peripheral T-cell Lymphoma Guided by Molecular Subtypes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement)
- •Relapsed or refractory disease after first line treatment
- •Availability of archival or freshly collected tumor tissue before study enrollment
- •Evaluable lesion by PET-CT or CT scan
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- •Life expectancy greater than or equal to (>/=) 3 months
- •Informed consent
排除标准
- •Patients with central nervous system (CNS) lymphoma
- •History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- •Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- •Neutrophils<1.0×10^9/L Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
- •Creatinine is 1.5 times higher than the ULN.
- •HIV-infected patients
- •Active hepatitis infection
- •Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- •Pregnant or lactation
- •Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease
研究组 & 干预措施
T1 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results
干预措施: Azacitidine Injection (Drug)
T1 subtypes based on next generation sequencing results
T1 subtypes based on next generation sequencing results
干预措施: Dasatinib (Drug)
T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
干预措施: Linperlisib (Drug)
T2 subtypes based on next generation sequencing results
T2 subtypes based on next generation sequencing results
干预措施: Azacitidine Injection (Drug)
T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
干预措施: Tucidinostat (Drug)
T3.1 subtypes based on next generation sequencing results
T3.1 subtypes based on next generation sequencing results
干预措施: SHR2554 (Drug)
T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
干预措施: Camrelizumab (Drug)
T3.2 subtypes based on next generation sequencing results
T3.2 subtypes based on next generation sequencing results
干预措施: Apatinib (Drug)
结局指标
主要结局
Overall response rate
时间窗: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)
Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
次要结局
- Complete response rate(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days))
- Progression-free survival(Baseline up to data cut-off (up to approximately 2 years))
- Overall survival(Baseline up to data cut-off (up to approximately 2 years))
- Duration of response(Baseline up to data cut-off (up to approximately 2 years))
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0(From enrollment to study completion, a maximum of 4 years)
研究者
Zhao Weili
First Deputy Director, Hematology Department
Ruijin Hospital