Golidocitnib treatment for relapsed 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

This study is testing if a new oral medication called Golidocitnib can help people with relapsed indolent T/NK-cell lymphomas feel better after other treatments haven't worked.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Tianjin, Tianjin Municipality and 1 other locations)
• Trial ID: NCT06716658 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Golidocitnib, a JAK1 inhibitor, in patients with relapsed or refractory indolent T/NK-cell lymphomas. The study plans to enroll 48 patients who have not responded to at least one prior systemic therapy. Participants will receive the treatment orally at a dose of 150mg once daily for up to 24 cycles, with efficacy assessed regularly throughout the treatment period. The goal is to determine the overall response rate and the feasibility of this therapeutic approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed relapsed or refractory indolent T/NK-cell lymphomas who have failed previous treatments.

Not a fit: Patients who have not been diagnosed with indolent T/NK-cell lymphomas or those who are not relapsed or refractory to treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with limited treatment choices for indolent T/NK-cell lymphomas.

How similar studies have performed: While there have been studies on JAK inhibitors for various conditions, this specific application for indolent T/NK-cell lymphomas is relatively novel.

Eligibility criteria

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.

Where this trial is running

Tianjin, Tianjin Municipality and 1 other locations

• Institute of Hematology & Blood Diseases Hospital, China — Tianjin, Tianjin Municipality, China (RECRUITING)
• Institute of Hematology & Blood Diseases Hospital — Tianjin, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Shuhua Yi, Doctor

Conditions: Lymphoma, T-Cell, NK-LGL Leukemia, T-LGL Leukemia, 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