RecruitingPhase 2NCT06716658

JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

48 participants

Start Date

Dec 25, 2024

Study Type

INTERVENTIONAL

Conditions

Lymphoma, T-Cell T-LGL Leukemia NK-LGL Leukemia Mycosis Fungoides Cutaneous T Cell Lymphoma (CTCL)Cutaneous T Cell Lymphoma Large Granular Lymphocyte Leukemia Large Granular Lymphocytic Leukemia Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma

Summary

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called golidocitnib — a JAK1 inhibitor (a type of targeted therapy) — in people with relapsed or refractory indolent T/NK-cell lymphomas (rare blood cancers affecting T or NK immune cells) that have not responded to or have come back after prior treatments. **You may be eligible if...** - You are 18 or older with confirmed relapsed or refractory indolent T/NK-cell lymphoma - You have failed at least one prior systemic therapy, or have no standard effective treatment options - You are in reasonable health (ECOG 0–2) - You have adequate heart, liver, and kidney function - Your prior treatments have had at least a 4-week washout period - You agree to use effective contraception **You may NOT be eligible if...** - You have previously used a JAK inhibitor - You have severe swallowing difficulties or digestive problems preventing oral medication - You have active central nervous system lymphoma - You have serious infections, uncontrolled heart disease, or are immunocompromised - You are pregnant or breastfeeding 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

DRUGJAK1 Inhibitor

Golidocitnib 150mg QD orally, with a 28-day cycle. Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first