[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"large-granular-lymphocyte-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:large-granular-lymphocyte-leukemia":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100571162","phase-2-jak1-inhibitor-golidocitnib-for-the-treatment-of-relapsedrefractory-indolent-tnk-cell-lymphomas-100571162",false,"NCT06716658","JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-cell Lymphomas","Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed\u002FRefractory Indolent T\u002FNK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years, with no restrictions on gender;\n2. Histologically confirmed relapsed\u002Frefractory (R\u002FR) indolent T\u002FNK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and\u002For currently has no effective standard treatment options;\n3. The patient meets the criteria for appropriate therapeutic indications;\n4. ECOG performance status of 0-2;\n5. Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)\u002FUrea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): \\\u003C 450 ms for males, \\\u003C 470 ms for females;\n6. An expected survival time of at least 3 months;\n7. 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;\n8. 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;\n9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;\n10. The subject agrees to and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects who have previously used any JAK inhibitors;\n2. Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and\u002For absorption of the study drug;\n3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);\n4. Subjects with HBV or HCV infections, defined as HBsAg and\u002For HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);\n5. 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;\n6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;\n7. Subjects with severe or uncontrolled cardiovascular diseases;\n8. 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);\n9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;\n10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;\n11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},48,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Indolent T\u002FNK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T\u002FNK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T\u002FNK-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\u002Frefractory indolent T\u002FNK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.",[26,27,28,29,30,31,32,33,34,35],"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",[37,38],"Indolent T\u002FNK-cell lymphomas","JAK1 inhibitor","RECRUITING","2025-11-14",{"date":42,"type":43},"2025-11-18","ACTUAL",{"date":45,"type":43},"2024-12-25",{"date":47,"type":20},"2028-11-15",{"name":49,"class":50},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",2]