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NCT Number: NCT07093710

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Guangzhou, Guangdong, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

golidocitinib

Drug

150mg, po, qd;

Mitoxantrone Hydrochloride Liposome

Drug

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

Chidamide

Drug

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

Primary outcomes

  1. Overall response rate(ORR) for Phase 2

    Time frame: Up to 24 months

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

  2. Maximum tolerated dose (MTD) for Phase 1b

    Time frame: The first cycle after administration

    To identify the MTD

Secondary outcomes

  1. Complete response rate (CRR)

    Time frame: Up to 24 months

    Defined as the proportion of patients who achieve complete remission as the best response

  2. Duration of Response(DOR)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  3. Progression-free survival(PFS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

  4. Overall survival(OS)

    Time frame: Up to 4 years

    To investigate the preliminary anti-tumor efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai

CONTACT

[email protected]

+862087342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Jul 30, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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