Golidocitinib with liposomal mitoxantrone or chidamide for 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
This trial tests whether adding golidocitinib to either liposomal mitoxantrone or chidamide helps adults with relapsed or refractory peripheral T‑cell lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | golidocitinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07093710 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open‑label phase Ib/II study testing the safety and activity of combining golidocitinib with either mitoxantrone hydrochloride liposome or the HDAC inhibitor chidamide in adults with relapsed or refractory peripheral T‑cell lymphoma. Phase Ib will identify tolerable dose levels and any dose‑limiting toxicities, and phase II will expand cohorts to measure antitumor activity. Responses will be measured using the Lugano 2014 lymphoma criteria and key endpoints include safety, objective response rate, duration of response, and progression‑free survival. Eligible patients must have measurable disease, ECOG 0–2, adequate organ and marrow function, and be able to receive treatment at participating sites.
Who should consider this trial
Good fit: Adults (≥18) with relapsed or refractory peripheral T‑cell lymphoma who have at least one measurable lesion, expected survival >12 weeks, ECOG 0–2, and adequate organ and marrow function are the ideal candidates.
Not a fit: Patients with CNS or meningeal lymphoma involvement, hemophagocytic lymphohistiocytosis (HLH), active uncontrolled infections, uncontrolled cardiac disease, or who cannot stop strong CYP3A inhibitors are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, these combinations could produce higher response rates and longer remissions than currently available salvage options for relapsed or refractory PTCL.
How similar studies have performed: Chidamide has shown single‑agent activity in PTCL and some combination approaches have shown promise, but combining golidocitinib with liposomal mitoxantrone or chidamide is a relatively novel approach without established proof of superiority.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Qingqing Cai
- Email: caiqq@sysucc.org.cn
- Phone: +862087342823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.