RecruitingPhase 1Phase 2NCT07093710

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

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


Sponsor

Sun Yat-sen University

Enrollment

101 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two different drug combinations — golidocitinib with either a chemotherapy drug (mitoxantrone hydrochloride liposome) or a targeted drug (chidamide) — for people with peripheral T-cell lymphoma (a type of aggressive blood cancer) that has come back or not responded to previous treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with peripheral T-cell lymphoma that has relapsed or not responded to prior treatment - You have at least one measurable area of cancer - You are in reasonably good physical health (ECOG 0–2) - Your organs and bone marrow are functioning adequately - You have a life expectancy of more than 12 weeks **You may NOT be eligible if...** - You have a rare serious condition called hemophagocytic lymphohistiocytosis (HLH, where the immune system attacks the body) - Your lymphoma has spread to the brain or spinal cord - You have an active uncontrolled infection - You have serious uncontrolled heart problems - You take certain medications that strongly interact with the study drugs (CYP3A inhibitors/inducers or blood thinners) - You have HIV/AIDS Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGolidocitinib

150mg, po, qd;

DRUGMitoxantrone Hydrochloride Liposome

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

DRUGChidamide

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


Locations(1)

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

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT07093710


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