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Recruiting Phase 1/2

Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

NCT07093710 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-08-27
Last updated
2025-12-31

Condition(s) studied

Peripheral T Cell Lymphoma

Investigational drug(s) / intervention(s)

Golidocitinib →Mitoxantrone Hydrochloride Liposome →Chidamide →

Golidocitinib: 150mg, po, qd;

Mitoxantrone Hydrochloride Liposome: Cohort 1: 15 mg/m2, IV, D1 and 18 mg/m2, IV, D1 (phase Ib); RP2D (II study)

Chidamide: Cohort 2: Chidamide:20mg/30mg, po, Biw (phase Ib); RP2D (phase II study)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 MTD

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07093710 on ClinicalTrials.gov ↗ ← All trials in China