[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extranodal-nkt-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extranodal-nkt-cell-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,81,103,130,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645062","phase-3-bridge-nk-immunotherapy-versus-chemotherapy-induction-followed-by-autologous-hsct-in-advanced-nktcl-100645062",false,"NCT07678229","BRIDGE-NK: Immunotherapy Versus Chemotherapy Induction Followed by Autologous HSCT in Advanced NKTCL","BRIDGE-NK: A Randomized, Open-Label, Prospective Phase III Study of Immunotherapy Induction Versus Chemotherapy Induction Followed by Autologous Hematopoietic Stem Cell Transplantation Consolidation in Newly Diagnosed Advanced Extranodal NK\u002FT-Cell Lymphoma","BRIDGE-NK","Inclusion Criteria:\n\n* Age 18 to 70 years at the time of signing informed consent.\n* Histologically confirmed extranodal NK\u002FT-cell lymphoma according to the current classification criteria, with tumor tissue confirmed to be EBER positive. Central pathology review is recommended.\n* Stage IV disease according to Lugano 2014 staging criteria, with baseline staging including PET\u002FCT and bone marrow evaluation.\n* Previously untreated disease, with no prior systemic anti-lymphoma therapy, radiotherapy, or other anti-tumor treatment for NKTCL.\n* At least one evaluable lesion assessable by PET\u002FCT and\u002For contrast-enhanced CT\u002FMRI.\n* Eastern Cooperative Oncology Group performance status score of 0 to 3.\n* Adequate hematologic function during screening, defined as absolute neutrophil count ≥1.0 × 10\\^9\u002FL, hemoglobin \\>80 g\u002FL, and platelet count \\>50 × 10\\^9\u002FL.\n* Adequate hepatic and renal function during screening, defined as alanine aminotransferase and aspartate aminotransferase ≤2 × upper limit of normal, total bilirubin ≤2 × upper limit of normal, and creatinine clearance ≥60 mL\u002Fmin.\n* No severe uncontrolled coagulation disorder, and judged by the investigator to be able to receive pegaspargase-containing therapy.\n* Judged by the investigator to have no absolute contraindication to key components of the assigned treatment strategy, including irreversible contraindication to high-dose methotrexate, severe organ dysfunction precluding transplant evaluation, or other conditions clearly preventing completion of the protocol-defined strategy.\n* Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Prior systemic anti-lymphoma therapy, radiotherapy, or investigational anti-tumor therapy.\n* Active central nervous system lymphoma involvement, including active brain parenchymal, meningeal, cerebrospinal fluid, or intraocular involvement.\n* Active infection requiring intensive care support, or infection judged by the investigator to be uncontrolled and likely to significantly interfere with protocol treatment.\n* Known history of acute or chronic pancreatitis, or any condition judged by the investigator to be an absolute contraindication to pegaspargase.\n\nFulminant disseminated intravascular coagulation, or severe coagulation disorder judged by the investigator to be uncorrectable in the short term and to substantially increase treatment risk.\n\n* Severe cardiac, pulmonary, hepatic, renal, or other major organ dysfunction that, in the investigator's judgment, would significantly interfere with protocol treatment.\n* Irreversible contraindication to high-dose methotrexate, including but not limited to marked renal failure, inability to receive standardized hydration, alkalization, leucovorin rescue, or methotrexate clearance monitoring, or any condition judged by the investigator to prevent safe administration of methotrexate within the protocol-defined strategy.\n* Active hepatitis C virus infection, human immunodeficiency virus infection, or active uncontrolled hepatitis B virus replication.\n* Uncontrolled severe hypertension, active bleeding, recent major thromboembolic event, or vascular high-risk condition judged by the investigator to preclude safe administration of anlotinib.\n* Pregnant or breastfeeding women, or participants of reproductive potential unwilling to use effective contraception during the study.\n* Any other medical, psychological, social, or compliance-related condition that, in the investigator's judgment, makes the participant unsuitable for this study.","ALL","18 Years","70 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a randomized, open-label, prospective, multicenter phase III superiority study in patients with newly diagnosed stage IV extranodal NK\u002FT-cell lymphoma. The study compares two frontline induction strategies followed by consolidation with autologous hematopoietic stem cell transplantation in patients who achieve a protocol-defined strict complete remission.\n\nEligible participants will be randomized 1:1 to Arm A or Arm B, stratified by three-level PINK-E risk category. Arm A consists of one cycle of GELAD induction followed by three cycles of MEDA chemotherapy. Participants who achieve strict complete remission after key response assessment will proceed to autologous hematopoietic stem cell transplantation consolidation. Arm B consists of four cycles of LEAP induction with sintilimab, pegaspargase, and anlotinib. Participants who achieve strict complete remission will receive high-dose methotrexate CNS-directed consolidation followed by autologous hematopoietic stem cell transplantation consolidation if eligible.\n\nThe primary endpoint is event-free survival within 24 months after randomization. Secondary endpoints include progression-free survival, overall survival, overall response rate, complete remission rate, strict complete remission rate, autologous hematopoietic stem cell transplantation completion rate, cumulative incidence of relapse, grade 3 or higher adverse events, treatment discontinuation, treatment-related mortality, and plasma EBV-DNA clearance dynamics.",[28],"Extranodal NK\u002FT-cell Lymphoma",[30,31,32,33,34,35,36],"Extranodal NK\u002FT-cell lymphoma","Epstein-Barr virus","Sintilimab","Pegaspargase","Anlotinib","Methotrexate","Autologous hematopoietic stem cell transplantation","NOT_YET_RECRUITING","2026-06-24",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":40,"type":22},{"date":44,"type":22},"2031-12-31",{"name":46,"class":47},"Rong Tao","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":48},"100631598","phase-1-tislelizumab-plus-zeprumetostat-for-relapsed-or-refractory-nkt-cell-lymphoma-100631598","NCT07502768","Tislelizumab Plus Zeprumetostat for Relapsed or Refractory NK\u002FT-Cell Lymphoma","A Multicenter, Open-Label, Seamless Phase Ib\u002FII Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK\u002FT-Cell Lymphoma","EpiRev-NKT","Inclusion Criteria:\n\n* Age 18 years or older.\n* Pathologically confirmed NK\u002FT-cell lymphoma.\n* Relapsed or refractory disease after at least 1 prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy.\n* At least 1 measurable or evaluable lesion according to Lugano 2014 criteria.\n* ECOG performance status 0 to 2.\n* Life expectancy greater than 12 weeks.\n* Adequate hematologic, hepatic, renal, coagulation, and cardiac function.\n* Recovery from prior anti-cancer treatment-related toxicities to CTCAE grade 1 or baseline, except for specified stable irreversible toxicities allowed by the investigator.\n* Negative pregnancy test for women of childbearing potential.\n* Willingness to use effective contraception.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Prior treatment with any EZH1\u002F2 or EZH2 inhibitor.\n* Allogeneic hematopoietic stem cell transplantation within 5 years before study treatment.\n* Autologous hematopoietic stem cell transplantation within 3 months before study treatment.\n* Requirement for high-dose systemic corticosteroids or other immunosuppressive therapy within 14 days before study treatment, except permitted local\u002Finhaled or short-course use.\n* Cytotoxic chemotherapy not discontinued within 14 days before study treatment.\n* Systemic anti-cancer therapy or investigational therapy within 4 weeks before study treatment.\n* Major surgery within 4 weeks or radiotherapy within 90 days before study treatment.\n* Active infection, including active\u002Flatent tuberculosis, HIV infection, active hepatitis B or C with detectable viral nucleic acid, or other clinically significant active viral infection.\n* Uncontrolled cardiovascular disease.\n* Persistent unresolved toxicities greater than CTCAE grade 1 from prior therapy, except alopecia.\n* Gastrointestinal disorders or prior intestinal surgery that may impair oral drug absorption.\n* Pregnancy or breastfeeding.\n* Psychiatric illness or inability to provide informed consent.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for the study.",{"count":58,"type":22},107,[60,61],"PHASE1","PHASE2","This is a multicenter, open-label, phase Ib\u002FII study evaluating tislelizumab in combination with zeprumetostat (SHR2554) in patients with relapsed or refractory NK\u002FT-cell lymphoma after at least one prior asparaginase-based chemotherapy-containing regimen, with or without radiotherapy. In phase Ib, two fixed dose levels of zeprumetostat in combination with tislelizumab will be evaluated to determine the recommended phase II dose (RP2D). In phase II, patients will be enrolled into 2 predefined cohorts according to prior exposure to PD-1 inhibitors to further evaluate efficacy and safety. The primary phase II endpoint is objective response rate at week 12 assessed by independent blinded imaging review according to Lugano 2014 criteria.",[28,64,65],"NK\u002FT-cell Lymphoma","Relapsed or Refractory NK\u002FT-Cell Lymphoma",[67,68,69,70,71],"Tislelizumab","Zeprumetostat","EZH2 inhibitor","PD-1 inhibitor","NKTCL","RECRUITING","2026-06-16",{"date":75,"type":41},"2026-06-18",{"date":77,"type":41},"2026-04-30",{"date":79,"type":22},"2028-12-30",{"name":46,"class":47},{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100493076","phase-3-study-of-sugemalimab-or-placebo-plus-pgemox-regimen-in-participants-with-extranodal-nkt-cell-lymphoma-100493076","NCT05700448","Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK\u002FT-Cell Lymphoma","A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK\u002FT-Cell Lymphoma (R\u002FR ENKTL)","Inclusion Criteria:\n\n* Has ENKTL histologically confirmed by the study center. Nasal and non-nasal ENKTL are both allowed.\n* Has relapsed or refractory ENKTL after prior asparaginase-based chemotherapy or chemoradiotherapy.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Has at least one measurable lesion per Lugano 2014 classification.\n* Is willing to provide stained tumor tissue sections and corresponding pathological reports or unstained tumor tissue sections (or tissue block) for central pathology review.\n* Has adequate organ function.\n* Has life expectancy of greater than 3 months.\n\nExclusion Criteria:\n\n* Has aggressive natural killer-cell leukemia, current central nervous system (CNS) involvement or is concomitant with hemophagocytic lymphohistiocytosis.\n* Has known additional malignancy within 5 years prior to randomization.\n* Has an active autoimmune disease or has had an autoimmune disease that may relapse.\n* Has had a major surgical procedure within 28 days or radiotherapy within 90 days before the first dose of study treatment.\n* Has active tuberculosis infection.\n* Has a known history of human immunodeficiency virus (HIV) infection and\u002For acquired immune deficiency syndrome (AIDS).\n* Has a known active Hepatitis B or C virus infection.\n* Has received systemic anti-cancer therapy within 28 days before the first dose of study treatment, including chemotherapy, immunotherapy, biological therapy (e.g. cancer vaccine, cytokine therapy or growth factors to treat cancer).\n* Has used traditional Chinese medicines or herbal preparations with anti-tumor indications within 7 days before the first dose of study treatment.\n* Has received systemic corticosteroid or any other immunosuppressive therapy within 14 days before the first dose of study treatment.\n* Has received any treatment of antibody or drug that targets at T-cell coregulatory pathways or immune checkpoint pathways.\n* Has toxicity from prior anti-cancer treatment, except for alopecia and fatigue, that has not recovered to baseline or ≤ Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 before the first dose of study treatment.\n* Has had allogenic hematopoietic stem cell transplantation (HSCT) within 5 years or autologous HSCT within 90 days before the first dose of study treatment.\n* Has a known severe hypersensitivity to sugemalimab, its active substance and\u002For any of its excipients, or to other monoclonal antibodies.\n* Female participants who are pregnant or breastfeeding.\n* Is currently participating in or has participated in a trial of an investigational agent within 28 days before to the first dose of study treatment.","75 Years",{"count":21,"type":22},[25],"The purpose of this study is to evaluate the efficacy and safety of sugemalimab (CS1001) in combination with PGemOx regimen (pegaspargase, gemcitabine, oxaliplatin) in treatment of adult patients with Extranodal NK\u002FT-Cell Lymphoma (ENKTL) who have relapsed or become refractory to asparaginase-based regimens.",[28],"2026-05-26",{"date":95,"type":41},"2026-05-27",{"date":97,"type":22},"2027-06",{"date":99,"type":22},"2030-12",{"name":101,"class":102},"CStone Pharmaceuticals","INDUSTRY",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":48},"100635576","phase-2-selinexor-combined-with-reduced-dose-radiotherapy-for-early-stage-extranodal-nkt-cell-lymphoma-100635576","NCT07554482","Selinexor Combined With Reduced-Dose Radiotherapy For Early-Stage Extranodal NK\u002FT-Cell Lymphoma","A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Selinexor Combined With Reduced-Dose Radiotherapy in the Treatment of Early-Stage Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Aged 18 to 75 years, regardless of gender.\n* Pathologically confirmed extranodal NK\u002FT-cell lymphoma (ENKTCL).\n* Ann Arbor stage I-II disease with primary lesion located in the nasal cavity or upper aerodigestive tract (UADT).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Treatment-naïve patients with no prior radiotherapy, chemotherapy or targeted therapy.\n* Adequate major organ function as follows:\n* Hematopoietic function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count (PLT) ≥100×10⁹\u002FL, hemoglobin (Hb) ≥90 g\u002FL.\n* Hepatic function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine transaminase (ALT) \u002F aspartate transaminase (AST) ≤2.5×ULN.\n* Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL\u002Fmin.\n* Cardiac function: left ventricular ejection fraction (LVEF) ≥50%.\n* Expected overall survival ≥6 months.\n* Voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Non-nasal type ENKTCL, or primary lesions outside the upper aerodigestive tract (UADT), including skin, gastrointestinal tract, lung and other sites.\n* Patients with Ann Arbor stage III-IV disease.\n* Central nervous system involvement.\n* History of prior malignant tumors, excluding non-melanoma skin cancer or cervical carcinoma in situ cured for more than 5 years.\n* Active infections, including active hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) infection.\n* Severe complications, such as uncontrolled diabetes mellitus and severe cardiopulmonary diseases.\n* Pregnant or lactating women.\n* Hypersensitivity or contraindication to any investigational drugs in this study.\n* Concurrent participation in other interventional clinical trials.",{"count":111,"type":22},34,[61],"Extranodal NK\u002FT-cell lymphoma (ENKTCL) is an Epstein-Barr virus-associated non-Hodgkin lymphoma with high incidence in Asia and Latin America. Approximately 70% of patients present with early-stage (I-II) disease confined to the upper aerodigestive tract. Radiotherapy at 50-56 Gy is the standard curative treatment, but high-dose radiotherapy causes severe toxicities including oral mucositis and xerostomia, while radiotherapy alone yields high systemic recurrence rates. Previous studies have confirmed the efficacy of P-GEMOX induction chemotherapy, verified the feasibility of reduced-dose radiotherapy in patients achieving complete response after chemotherapy, and demonstrated the radiosensitizing effect of selinexor via inhibiting IRF3-BARD1-BRCA1-mediated DNA damage repair. Moreover, international evidence supports the efficacy of 40 Gy radiotherapy combined with chemotherapy. Accordingly, this study hypothesizes that selinexor combined with 40 Gy reduced-dose radiotherapy following P-GEMOX induction chemotherapy can achieve equivalent efficacy to standard-dose radiotherapy, while markedly decreasing radiotherapy-related toxicities. This trial innovatively applies selinexor as a radiosensitizer in ENKTCL, fulfills the unmet clinical demand for efficacy-preserving toxicity reduction, and is well supported by preliminary data.",[28],[116,117,118,119,120],"extranodal NK\u002FT-cell lymphoma","selinexor","XPO1 inhibitor","radiotherapy","reduced-dose radiotherapy","2026-04-21",{"date":123,"type":41},"2026-04-28",{"date":125,"type":22},"2026-05-15",{"date":127,"type":22},"2029-04-30",{"name":129,"class":47},"Beijing Tongren Hospital",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100622620","phase-2-golidocitinib-combined-with-p-gemox-plus-pd-1-inhibitor-versus-p-gemox-plus-pd-1-inhibitor-in-first-line-newly-diagnosed-advanced-or-non-nasal-extranodal-nkt-cell-lymphoma-100622620","NCT07385989","Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in First-Line Newly Diagnosed Advanced or Non-Nasal Extranodal NK\u002FT-Cell Lymphoma","A Randomized Controlled Multicenter Phase 2 Clinical Trial of Golidocitinib Combined With P-GemOx Plus PD-1 Inhibitor Versus P-GemOx Plus PD-1 Inhibitor in the Treatment of First-Line Newly Diagnosed Advanced Extranodal NK\u002FT-Cell Lymphoma (ENKTL) or Non-Nasal Extranodal NK\u002FT-Cell Lymphoma (ENKTL)","Inclusion Criteria:\n\n1. Voluntarily provides written informed consent (ICF) prior to any study procedures.\n2. Aged 18-70 years (inclusive), regardless of sex.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Histologically confirmed extranodal NK\u002FT-cell lymphoma (ENKTL), staged as Stage III-IV or non-nasal ENKTL (per 2016 WHO Classification of Hematopoietic and Lymphoid Tumors).\n5. At least one measurable\u002Fevaluable lesion (per 2014 Lugano Classification: measurable lesion ≥1.5 cm in longest diameter + ≥1.0 cm in shortest diameter; evaluable lesion with FDG uptake higher than liver on PET\u002FCT).\n6. Treatment-naive (no prior anti-cancer therapy for ENKTL).\n7. Adequate organ function:\n\n   AST\u002FALT ≤2.5×upper limit of normal (ULN); Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine \\\u003C1.5×ULN or creatinine clearance (CrCl, via Cockcroft-Gault formula) ≥60 mL\u002Fmin.\n8. Reproductive-aged females have a negative pregnancy test at screening; all participants use effective contraception during the study and for 12 months after the last dose.\n9. Expected survival ≥6 months.\n\nExclusion Criteria:\n\n1. Complicated by hemophagocytic lymphohistiocytosis (HLH) or aggressive NK-cell leukemia.\n2. Contraindication to golidocitinib, PD-1 inhibitor, or any component of the P-GEMOX regimen.\n3. Lymphoma involvement of the central nervous system (CNS).\n4. Major surgery (excluding diagnostic biopsy) within 4 weeks prior to study treatment initiation.\n5. History of other malignant tumors (except curatively treated in situ cancers, e.g., cervical carcinoma in situ) within 5 years.\n6. Uncontrolled severe comorbidities (e.g., NYHA Class II+ heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmias).\n7. Active bleeding (e.g., gastrointestinal hemorrhage, cerebral hemorrhage).\n8. Uncontrolled infection (requiring parenteral anti-infective therapy) within 7 days prior to study treatment.\n9. Active hepatitis B\u002FC: HBsAg+\u002FHBcAb+ with HBV-DNA \\>2500 copies\u002FmL (or 500 IU\u002FmL); HCV antibody+ with positive HCV-RNA.\n10. HIV infection or acquired immunodeficiency syndrome (AIDS).\n11. Conditions impairing drug absorption (e.g., inability to swallow tablets, malabsorption syndrome).\n12. Pregnant\u002Flactating females, or reproductive-aged participants refusing contraception.\n13. Psychiatric illness precluding informed consent or study compliance.\n14. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":138,"type":22},40,[61],"This is a multicenter, randomized, Phase 2 clinical trial designed to evaluate the efficacy and safety of golidocitinib combined with the P-GemOx (pegaspargase + gemcitabine + oxaliplatin) regimen plus PD-1 inhibitor, compared with P-GemOx plus PD-1 inhibitor alone, in participants with first-line newly diagnosed advanced (Stage III-IV) or non-nasal extranodal natural killer\u002FT-cell lymphoma (ENKTL). Eligible participants will be randomly assigned 1:1 to two groups:\n\nExperimental group: Golidocitinib (150 mg orally once daily, Days 1-21 per 21-day cycle) + P-GemOx (pegaspargase 2000 U\u002Fm² on Day 2; gemcitabine 1000 mg\u002Fm² on Day 1; oxaliplatin 100 mg\u002Fm² on Day 1, per 21-day cycle) + PD-1 inhibitor (200 mg intravenously on Day 1 per 21-day cycle).\n\nControl group: P-GemOx + PD-1 inhibitor (same dosage\u002Fschedule as the experimental group, without golidocitinib). All participants will receive 6 cycles of induction therapy. Those achieving CR or partial response (PR) after induction will receive maintenance therapy for 1 year: the experimental group will continue golidocitinib + PD-1 inhibitor, while the control group will receive PD-1 inhibitor alone (both per 21-day cycles). The primary outcome is the complete response rate (CRR) after 6 induction cycles (assessed per the 2014 Lugano Classification for Lymphoma). Secondary outcomes include overall response rate (ORR), 2-year progression-free survival (PFS), 2-year overall survival (OS), and the incidence of treatment-related adverse events (graded per NCI-CTCAE Version 5.0). 40 participants will be enrolled across multiple Chinese medical centers. This Phase 2 trial will provide preliminary evidence to determine whether the golidocitinib combination regimen is a safe and effective first-line option for advanced or non-nasal ENKTL.",[28],"2026-01-27",{"date":144,"type":41},"2026-02-04",{"date":146,"type":22},"2026-01-25",{"date":148,"type":22},"2032-12-31",{"name":150,"class":47},"WEI XU",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":48},"100579483","phase-2-sintilimab-pegaspargase-plus-gemox-for-untreated-extranodal-nkt-cell-lymphoma-100579483","NCT06824883","Sintilimab, Pegaspargase Plus GemOx for Untreated Extranodal NK\u002FT-Cell Lymphoma","A Single-arm, Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin (P-P-GEMOX) Regimen for Newly Diagnosed Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Histopathologically confirmed diagnosis of extranodal NK\u002FT-cell lymphoma (ENKTL) by the study center.\n* Age between 18 and 75 years.\n* At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA \\> 500 copies\u002FmL.\n* ECOG performance status of 0 to 3.\n* Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (≥ 1.0 × 10⁹\u002FL in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹\u002FL (≥ 50 × 10⁹\u002FL in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g\u002FL.\n* Adequate organ function: Alanine aminotransferase (ALT) \\\u003C 3 × the upper limit of normal (ULN); Total bilirubin (TBil) \\\u003C 1.5 × ULN; Serum creatinine \\\u003C 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) \\> 50%.\n\nExclusion Criteria:\n\n* Aggressive NK-cell leukemia.\n* Central nervous system lymphoma.\n* History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) \\> 480 ms.\n* Uncontrolled active infection.\n* Pregnant or breastfeeding women.",{"count":159,"type":22},49,[61],"This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.",[28],"2025-02-08",{"date":165,"type":41},"2025-02-13",{"date":167,"type":41},"2024-05-20",{"date":169,"type":22},"2027-05-20",{"name":171,"class":47},"Peking Union Medical College Hospital"]