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

ConditionsLymphoma, T-CellNK-LGL LeukemiaT-LGL LeukemiaCutaneous T Cell LymphomaCutaneous T Cell Lymphoma (CTCL)Large Granular Lymphocyte LeukemiaLarge Granular Lymphocytic LeukemiaIndolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal TractPrimary Cutaneous Acral CD8-Positive T-Cell LymphomaMycosis Fungoides
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, with no restrictions on gender;

Histologically confirmed relapsed/refractory (R/R) indolent T/NK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and/or currently has no effective standard treatment options;

The patient meets the criteria for appropriate therapeutic indications;

ECOG performance status of 0-2;

Disqualifiers

Subjects who have previously used any JAK inhibitors;

Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;

Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);

Subjects with HBV or HCV infections, defined as HBsAg and/or HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);

Trial design

Design model

Single group

Treatments tested in this trial

  • JAK1 Inhibitor

    Drug

    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

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: JAK1 inhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall response rate

complete remission rate + partial remission rate

Time frame
up to 5 years

Secondary outcomes

1

The safety of JAK1 inhibitor

Incidence of adverse events, serious adverse events and significant adverse event

Time frame
up to 5 years
2

Complete remession rate

Hematological PR was defined as an improvement in blood counts ANC \> 0.5 × 109/L; HGB increased by \>1 g/dL; PLT \> 50 × 109/L

Time frame
up to 5 years
3

Duration of remission

the time from response to progression/death (P/D)

Time frame
up to 5 years
4

Time to response

from the start of treatment to the first observed partial remission

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Tianjin First Central Hospital

Collaborator

The First Affiliated Hospital of Air Force Medicial University

Collaborator

The First Hospital of Jilin University

Collaborator

The First Affiliated Hospital of Nanchang University

Collaborator

Henan Cancer Hospital

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Tongji Hospital

Collaborator

Source ClinicalTrials.gov
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