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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Peripheral T Cell Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07093710

B2025-346

Details and patient eligibility

About

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

Enrollment: 101 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

Experimental group

Description:

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.

Treatment:

Drug: Chidamide

Drug: Mitoxantrone Hydrochloride Liposome

Drug: Golidocitinib