Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

Summary

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

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

Conditions2

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