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

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.

Conditions

• Lymphoma, T-Cell
• NK-LGL Leukemia
• T-LGL Leukemia
• Cutaneous T Cell Lymphoma
• Cutaneous T Cell Lymphoma (CTCL)
• 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
• Mycosis Fungoides

Interventions

DRUG

JAK1 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

Sponsors & Collaborators

• Tianjin First Central Hospital

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• Henan Cancer Hospital

  collaborator OTHER_GOV

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Institute of Hematology & Blood Diseases Hospital, China

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-25

Primary Completion

2026-11-15

Completion

2028-11-15

Countries

• China

Study Locations