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Not yet recruiting NCT07347288

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

Phase II Interventional PTCL

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR2554 Tablets.
Who it may be relevant to
Registry conditions: PTCL. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug SHR2554 Tablets
    SHR2554 orally twice daily

Primary outcome measures

  • 2 years PFS [Time frame: 2 years]
Secondary outcome measures (7)
  • 1-year and 2-year DFS rates for patients who were in CR at enrollment [Time frame: 1year,2year]
  • Rate of patients who were PR at enrollment converting to CR [Time frame: Time from the first dose to any events, assessed up to 12 months]
  • Complete Response Rate (CR) [Time frame: Time from the first dose to disease progression or death, assessed up to 12months]
  • Duration of Response (DoR) [Time frame: From the date response is first documented to the date of disease progression or death, up to 36 months]
  • Progression-Free Survival (PFS) [Time frame: Time from the first dose to disease progression or death, assessed up to 36 months]
  • Overall Survival (OS) [Time frame: Time from the first dose to death from any cause, assessed up to 36 months]
  • Incidence of Treatment-Related Adverse Events (Safety and Tolerability) [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07347288 · 2025-SR-1121

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗