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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qingqing Cai
caiqq@sysucc.org.cn
+862087342823
Time Frame
Start Date:2025-08-27
Estimated Completion Date:2029-08-01
Participants
Target number of participants:101
Treatments
Experimental: Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx
In Cohort 1, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Mitoxantrone Hydrochloride Liposome, with an initial dose of 15mg/m² of Liposomal Mitoxantrone. Two dose groups are designed: 15mg/m² and 18mg/m². Each treatment cycle is 28 days. The Mitoxantrone Hydrochloride Liposome injection will be combined with Golidocitinib(150mg, qd) at the RP2D dose level for an extension study.~In Cohort 2, patients will receive 150mg of Golidocitinib, orally once daily (qd), in combination with Chidamide, with an initial dose of 20 mg (biw) of Chidamide. Two dose groups are designed: 20 mg and 30 mg. Each treatment cycle is 28 days. The Chidamide will be combined with Golidocitinib (150mg, qd) at the RP2D dose level for an extension study.