NCT07347288尚未招募2 期
An Open-label, Multicenter Exploratory Clinical Study of the EZH2 Inhibitor SHR2554 as Maintenance Therapy After First-line Systemic Treatment in Patients With Peripheral T-cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2 years PFS
研究概览
简要总结
Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma
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
- •Age ≥18 years old
- •Histologically confirmed PTCL,including PTCL NOS, ALCL, nTFHL,MEITL,ENKTL etc. according to WHO 2022 criteria.
- •Previously received first-line systemic induction therapy and achieved CR/PR; Auto-transplantation or allo-transplantation are allowed.
- •A measurable or evaluable disease at the time of first diagnosis of PTCL (any nodes/nodal masses>1.5 cm in longest diameter (LDi) or extralymphatic sites of disease >1.0 cm in LDi)
- •ECOG PS 0-2
- •With adequate organ function
- •Expected survival ≥ 12 weeks
- •Women of childbearing potential (WOCBP) should be proven to be negative by human chorionic gonadotropin (hCG) test in 7 days before the first dose of SHR
- •They must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from the day they sign the informed consent form (ICF) to at least 30 days after receiving the last dose of study treatment. Male subjects with WOCBP partner should receive Surgical sterilization or consent to employ a highly effective method of birth control/contraception to prevent pregnancy；
- •Participant who has provided written consent to participate in the study and ability to comply with all aspects of the protocol.
排除标准
- •cutaneous T cell lymphoma
- •Has a prior malignancy other than the malignancies under study within 3 years without relieve
- •Participants with a presence of central nerves invasion
- •Known sensitivity or allergy to investigational product
- •Participated in another clinical trial within 4 weeks prior to the start of the study;
- •Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
- •Active infected persons, except tumor-related B symptom fever;
- •Diseases and medical history:
- •1.have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2.have a history of psychotropic substance abuse and can not quit or have mental disorders; 3.Subjects with any severe and/or uncontrolled medical condition; 9.A history of immunodeficiency 10.Patients with mental disorders or those unable to provide informed consent 11.In any conditions which investigator considered ineligible for this study.
研究组 & 干预措施
SHR2554 monotherapy
Experimental
Patients With Peripheral T-cell Lymphoma After First-line Systemic Treatment Receiving SHR2554 monotherapy as Maintenance Therapy
干预措施: SHR2554 Tablets (Drug)
结局指标
主要结局
2 years PFS
时间窗: 2 years
The 2-year rate of during and after treatment that the participant lives without progression of the disease, as assessed by 2014 Lugano criteria.
次要结局
- 1-year and 2-year DFS rates for patients who were in CR at enrollment(1year,2year)
- Rate of patients who were PR at enrollment converting to CR(Time from the first dose to any events, assessed up to 12 months)
- Complete Response Rate (CR)(Time from the first dose to disease progression or death, assessed up to 12months)
- Duration of Response (DoR)(From the date response is first documented to the date of disease progression or death, up to 36 months)
- Progression-Free Survival (PFS)(Time from the first dose to disease progression or death, assessed up to 36 months)
- Overall Survival (OS)(Time from the first dose to death from any cause, assessed up to 36 months)
- Incidence of Treatment-Related Adverse Events (Safety and Tolerability)(Up to 12 months)
研究者
研究点 (1)
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