JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Re...

About this study

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.

Condition: 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
Tested: JAK1 Inhibitor
Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Who can join

Age: 18 years and older
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 12

Minimum age: 18 years
Study condition: 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
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;
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;
An expected survival time of at least 3 months;
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;
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;
The subject has not participated in any other clinical trial within 1 month prior to enrollment;
The subject agrees to and signs the informed consent form.

Exclusion 11

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);
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;
Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
Subjects with severe or uncontrolled cardiovascular diseases;
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);
Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.

Where

2 sites, 2 recruiting

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, China

Recruiting

Institute of Hematology & Blood Diseases Hospital

Tianjin, China