Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
The Safety and Efficacy of Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Prospective, Multicenter, Open-label, Phase Ib/II Clinical Study
Sun Yat-sen University
101 participants
Aug 27, 2025
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria8
- 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
Interventions
150mg, po, qd;
Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)
Cohort 2: Chidamide：20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07093710