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

Phase 2

Recruiting

• 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

• Registration Number: NCT06716658
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Detailed Description

Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg 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.

Study Timeline

• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Status Verified: 2024-12
• Study First Posted: 2024-12-04
• Last Update Submitted: 2024-12-08
• Last Update Posted: 2024-12-10
• Study Start: 2024-12-15
• Primary Completion: 2026-11-15
• Study Completion: 2028-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Age ≥ 18 years, with no restrictions on gender;
2. 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;
3. The patient meets the criteria for appropriate therapeutic indications;
4. ECOG performance status of 0-2;
5. Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)/Urea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): < 450 ms for males, < 470 ms for females;
6. An expected survival time of at least 3 months;
7. Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;
8. A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;
9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;
10. The subject agrees to and signs the informed consent form.

Exclusion Criteria

1. Subjects who have previously used any JAK inhibitors;
2. 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;
3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
4. 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);
5. Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
7. Subjects with severe or uncontrolled cardiovascular diseases;
8. Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);
9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JAK1 inhibitor	JAK1 Inhibitor	Golidocitnib 150mg QD orally

Primary Outcome Measures

Name	Time	Method
Overall response rate	up to 5 years	complete remission rate + partial remission rate

Secondary Outcome Measures

Name	Time	Method
The safety of JAK1 inhibitor	up to 5 years	Incidence of adverse events, serious adverse events and significant adverse event
Complete remession rate	up to 5 years	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
Duration of remission	up to 5 years	the time from response to progression/death (P/D)
Time to response	up to 5 years	from the start of treatment to the first observed partial remission
Progression-free survival	up to 5 years	the time from treatment initiation until disease progression or death
Overall survival	up to 5 years	The time from the start of treatment to the patient's death from any cause
Disease control rate	up to 5 years	the proportion of patients whose tumors have not progressed after treatment over a specific period of time. Specifically, DCR includes the percentage of patients who achieve complete response (CR), partial response (PR), and stable disease (SD).

Trial Locations

Locations (2)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, China

Institute of Hematology & Blood Diseases Hospital, China; 🇨🇳 Tianjin, Tianjin, China