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

NCT ID: NCT07093710

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2029-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Peripheral T Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Golidocitinib Combined with Mitoxantrone Hydrochloride Liposome or GemOx

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.

Group Type EXPERIMENTAL

Golidocitinib

Intervention Type DRUG

150mg, po, qd;

Mitoxantrone Hydrochloride Liposome

Intervention Type DRUG

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

Chidamide

Intervention Type DRUG

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

Interventions

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Golidocitinib

150mg, po, qd;

Intervention Type DRUG

Mitoxantrone Hydrochloride Liposome

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

Intervention Type DRUG

Chidamide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Qingqing Cai

MD. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingqing Cai

Role: CONTACT

Phone: +862087342823

Email: [email protected]

Other Identifiers

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B2025-346

Identifier Type: -

Identifier Source: org_study_id