Not Yet RecruitingPhase 2

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

China30 participantsStarted 2026-02

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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；

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:

What they're measuring

2 years PFS

Timeframe: 2 years

Trial details

NCT IDNCT07347288

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Wei Xu, Doctor

86-2568302182 xuwei10000@hotmail.com

View on ClinicalTrials.gov More PTCL trials