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

NCT07093710 | Recruiting Phase 1

• 1 other identifier: B2025-346
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall response rate(ORR) for Phase 2

  The proportion of patients who achieve complete remission (CR) or partial remission (PR) as the best response.

  Up to 24 months

• Maximum tolerated dose (MTD) for Phase 1b

  To identify the MTD

  The first cycle after administration

Secondary Outcomes (4)

• Complete response rate (CRR)

  Up to 24 months

• Duration of Response(DOR)

  Up to 4 years

• Progression-free survival(PFS)

  Up to 4 years

• Overall survival(OS)

  Up to 4 years

Study Arms (1)

Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

EXPERIMENTAL

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.

Drug: Golidocitinib; Drug: Mitoxantrone Hydrochloride Liposome; Drug: Chidamide

Interventions

Golidocitinib DRUG

150mg, po, qd;

Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

Mitoxantrone Hydrochloride Liposome DRUG

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

Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

Chidamide DRUG

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

Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Qingqing Cai

CONTACT

+862087342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 30, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 31, 2025

Record last verified: 2025-07

Locations

CN (1)