NCT06716658

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

StatusRecruiting

PhasePhase 2

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Primary completionNov 15, 2026 (estimated)

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Record History

All 3 versions: 3 with changes below.

Minor Nov 14, 2025 Start date changed from estimate of Dec 15, 2024 to Dec 25, 2024
- Site contacts updated at 1 of 2 sites
v3
Minor Dec 8, 2024 Study sites: 1 to 2v2
Nov 29, 2024 Study First Submitted

Minor: routine updates

Endpoints

Primary

Overall response rate

Timeframe: up to 5 years

Secondary (7)

The safety of JAK1 inhibitor

Complete remession rate

Duration of remission

Time to response

Progression-free survival

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Overall survival

Disease control rate

Arms and interventions

JAK1 inhibitorExperimental

Golidocitnib 150mg QD orally

Drugs: JAK1 Inhibitor

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 48 participants (estimated)
Started: Dec 25, 2024
Study completion: Nov 15, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: Data monitoring committee
Conditions: Leukemia, Large Granular Lymphocytic, Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, NK-LGL Leukemia, T-LGL Leukemia, Cutaneous T Cell Lymphoma (CTCL), Large Granular Lymphocyte Leukemia +2 more
Collaborators: Tianjin First Central Hospital, The First Affiliated Hospital of Air Force Medicial University, The First Hospital of Jilin University, The First Affiliated Hospital of Nanchang University, Henan Cancer Hospital, Second Xiangya Hospital of Central South University, Tongji Hospital
Official title: Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial
First posted: Dec 4, 2024
Registry updated: Nov 18, 2025
Last verified: Nov 2025

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