NCT07725705尚未招募1 期
An Open-label, Multicenter, Phase Ib/II Exploratory Clinical Study of EZH2 Inhibitor SHR2554 in Combination With Liposomal Mitoxantrone for the First-line Treatment of Peripheral T-cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 44
- 主要终点
- Complete response (CR) rate
研究概览
简要总结
This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old,regardless of gender;
- •Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS; Enteropathy-associated T-cell lymphoma(EATL); Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
- •No prior anti-tumor therapy.
- •There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma: Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions >1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma;
- •ECOG performance status score: 0-2;
- •Expected survival time ≥3 months;
- •Have adequate organ and bone marrow functiont;
- •No concurrent hemophagocytic lymphohistiocytosis (HLH). If a patient has clinically diagnosed HLH, enrollment eligibility will be determined by the investigator based on an evaluation of the patient's general physical condition following targeted anti-HLH therapy.
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.
- •Capable of understanding the study procedures and voluntarily signing a written informed consent form (ICF).;
排除标准
- •Prior treatment with epigenetic agents before enrollment;
- •Patients with a history of severe cardiac disease, history of radiation therapy to the mediastinal/pericardial region, cumulative anthracycline dose > 550 mg (doxorubicin equivalent), prior use of mitoxantrone, baseline left ventricular ejection fraction (LVEF) < 50%, or history of exposure to other cardiotoxic drugs;
- •History of other primary aggressive malignancies that are not in remission, or have been in remission for less than 3 years;
- •Primary central nervous system (CNS) lymphoma or secondary CNS involvement.
- •Known allergy or hypersensitivity to the study drugs or their related metabolites;
- •Currently participating in another clinical study, or less than 4 weeks elapsed from the end of treatment in a previous clinical study to the planned start of study treatment;
- •Pregnant or lactating women;
- •Active infections;
- •Medical History and Concurrent Conditions;
- •History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS);
- •Patients with mental disorders or those unable to provide informed consent
- •Any other condition deemed by the investigator to be unsuitable for study enrollment;
研究组 & 干预措施
SHR2554 combined with Liposomal Mitoxantrone
Experimental
干预措施: SHR2554 combined with Liposomal Mitoxantrone (Drug)
结局指标
主要结局
Complete response (CR) rate
时间窗: up to 6 months after enrollment
The proportion of subjects evaluated as complete response (CR) according to Lugano 2014 efficacy evaluation criteria
Incidence of Dose-Limiting Toxicities (DLT)
时间窗: Cycle 1 (28 days)
Adverse events (AE) defined as DLT events per protocol
次要结局
- Objective response rate (ORR)(up to 6 months after enrollment)
- Duration of Response (DOR)(up to 2.5 years post first treatment)
- Duration of complete response (CR)(up to 2.5 years post first treatment)
- Progression-free Survival (PFS)(Up to 2.5 years)
- Overall survival (OS)(Up to 2.5 years)
- Adverse events(AE)(From the first day of medication to 28 days after the last dose)
研究者
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