This is a prospective, multicenter, open-label, phase Ib/II clinical study to evaluate the safety and efficacy of golidocitinib combined with mitoxantrone hydrochloride liposome or chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
* Diagnosed with PTCL according to the 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center
* Using the Lugano 2014 lymphoma efficacy evaluation criteria, the patient must have at least one measurable or evaluable lesion
* Age ≥ 18 years
* Expected survival greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate organ and bone marrow function
Exclusion Criteria:
* Accompanied by hemophagocytic lymphohistiocytosis (HLH)
* Lymphoma involvement in the central nervous system or meninges
* Active infections
* Uncontrolled clinical cardiac symptoms or diseases
* Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
* Currently using vitamin K antagonists, antiplatelet drugs, anticoagulants (or unable to stop them within one week prior to the start of the study treatment).
* History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
* Patients with mental disorders or those unable to provide informed consent
Primary outcome measure(s)
Overall response rate(ORR) for Phase 2 — Up to 24 months The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.
Maximum tolerated dose (MTD) for Phase 1b — The first cycle after administration To identify the MTD
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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