SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)
Starting soon · Phase 1/Phase 2
Conditions studied: PTCL, First Line Treatment
In brief
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.
Key facts
- Study ID
- NCT07725705
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 44
- Starts
- 2026-08-01
- Expected to finish
- 2030-03-01
- Last updated by the study team
- 2026-07-24
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).;
You may not qualify if…
- 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;
Full record on ClinicalTrials.gov
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