Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or GemOx in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
Not Applicable
Not yet recruiting
- Conditions
- Peripheral T Cell Lymphoma
- Interventions
- Registration Number
- NCT07093710
- Lead Sponsor
- Sun Yat-sen University
- Brief 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 GemOx in the treatment of relapsed or refractory peripheral T-cell lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 101
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 and ≤ 75 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx Golidocitinib 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, Golidocitinib will be administered at an initial dose of 150mg every other day (qod), with two dose groups: 150mg, orally, qod; and 150mg, orally, qd. GemOx will be given at fixed doses, with each treatment cycle lasting 21 days. Gemcitabine: 1g/m², intravenous injection, on Day 1; Oxaliplatin: 100mg/m², intravenous injection, on Day 1. Patients entering the dose expansion phase will receive Goliximab at the RP2D dose level, combined with GemOx. Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx 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, Golidocitinib will be administered at an initial dose of 150mg every other day (qod), with two dose groups: 150mg, orally, qod; and 150mg, orally, qd. GemOx will be given at fixed doses, with each treatment cycle lasting 21 days. Gemcitabine: 1g/m², intravenous injection, on Day 1; Oxaliplatin: 100mg/m², intravenous injection, on Day 1. Patients entering the dose expansion phase will receive Goliximab at the RP2D dose level, combined with GemOx. Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx Mitoxantrone Hydrochloride Liposome 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, Golidocitinib will be administered at an initial dose of 150mg every other day (qod), with two dose groups: 150mg, orally, qod; and 150mg, orally, qd. GemOx will be given at fixed doses, with each treatment cycle lasting 21 days. Gemcitabine: 1g/m², intravenous injection, on Day 1; Oxaliplatin: 100mg/m², intravenous injection, on Day 1. Patients entering the dose expansion phase will receive Goliximab at the RP2D dose level, combined with GemOx.
- Primary Outcome Measures
Name Time Method 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 MDT
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR) Up to 24 months Defined as the proportion of patients who achieve complete remission as the best response
Duration of Response(DOR) Up to 4 years To investigate the preliminary anti-tumor efficacy
Overall survival(OS) Up to 4 years To investigate the preliminary anti-tumor efficacy
Progression-free survival(PFS) Up to 4 years To investigate the preliminary anti-tumor efficacy