SHR2554 as Maintenance Therapy in Patients With Peripheral T-cell Lymphoma

Официальное название

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

Обзор

Evaluation of the Safety and Efficacy of SHR2554 as Maintenance Therapy after first-line systemic treatment in patients with peripheral T-cell lymphoma

Вмешательства

• Препарат SHR2554 Tablets
  SHR2554 orally twice daily

Первичные конечные точки

• 2 years PFS [Срок оценки: 2 years]

Вторичные конечные точки (7)

• 1-year and 2-year DFS rates for patients who were in CR at enrollment [Срок оценки: 1year,2year]
• Rate of patients who were PR at enrollment converting to CR [Срок оценки: Time from the first dose to any events, assessed up to 12 months]
• Complete Response Rate (CR) [Срок оценки: Time from the first dose to disease progression or death, assessed up to 12months]
• Duration of Response (DoR) [Срок оценки: From the date response is first documented to the date of disease progression or death, up to 36 months]
• Progression-Free Survival (PFS) [Срок оценки: Time from the first dose to disease progression or death, assessed up to 36 months]
• Overall Survival (OS) [Срок оценки: Time from the first dose to death from any cause, assessed up to 36 months]
• Incidence of Treatment-Related Adverse Events (Safety and Tolerability) [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• 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 SHR2554. 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07347288 · 2025-SR-1121

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗