NCT07093710 Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma
| NCT ID | NCT07093710 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Peripheral T Cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 101 participants in total. It began in 2025-08-27 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral T Cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07093710 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07093710 currently recruiting?
Yes, NCT07093710 is actively recruiting participants. Contact the research team at caiqq@sysucc.org.cn for enrollment information.
Where is the NCT07093710 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07093710 clinical trial?
NCT07093710 is sponsored by Sun Yat-sen University. The trial plans to enroll 101 participants.