[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"natural-killert-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:natural-killert-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,72,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100651950","phase-2-gelad-based-response-adapted-treatment-for-early-stage-extranodal-nkt-cell-lymphoma-100651950",false,"NCT07768943","GELAD-Based Response-Adapted Treatment for Early-Stage Extranodal NK\u002FT-Cell Lymphoma","A Prospective Multicenter Response-Adapted Treatment Study Based on Early Response Assessment After GELAD Induction Chemotherapy in Early-Stage Extranodal NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18 to 75 years, inclusive.\n* Histologically confirmed extranodal NK\u002FT-cell lymphoma, nasal type, according to the 2022 World Health Organization classification.\n* Diagnosis confirmed by institutional or central pathological review. Tumor tissue must be adequate for morphological assessment, immunohistochemistry, and Epstein-Barr virus-encoded RNA in situ hybridization.\n* Lugano 2014 stage IE or IIE disease with a primary site in the upper aerodigestive tract, including but not limited to the nasal cavity, paranasal sinuses, nasopharynx, oropharynx, or oral cavity.\n* At least one disease lesion evaluable by PET\u002FCT at baseline.\n* No previous chemotherapy, radiotherapy, immunotherapy, or other antitumor biological therapy for lymphoma.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Adequate organ function, including:\n\n  * Absolute neutrophil count at least 1.0 x 10\\^9\u002FL.\n  * Platelet count at least 75 x 10\\^9\u002FL.\n  * Hemoglobin at least 90 g\u002FL.\n  * No granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 14 days before enrollment.\n  * Total bilirubin no greater than 1.5 times the upper limit of normal.\n  * Alanine aminotransferase and aspartate aminotransferase no greater than 2 times the upper limit of normal.\n  * Serum creatinine no greater than 1.5 times the upper limit of normal.\n  * Fibrinogen at least 1.5 g\u002FL.\n  * Left ventricular ejection fraction at least 50%.\n* Ability to understand the study and provide written informed consent.\n* Willingness to comply with protocol treatment, follow-up, laboratory testing, imaging assessments, and biospecimen collection.\n\nExclusion Criteria:\n\n* Diagnosis not meeting the 2022 World Health Organization criteria for extranodal NK\u002FT-cell lymphoma or not confirmed after pathological review.\n* Lugano stage III or IV disease or distant organ involvement inconsistent with localized early-stage disease.\n* Primary disease outside the upper aerodigestive tract or predominantly systemic or widespread extranodal disease.\n* Previous lymphoma-directed chemotherapy, radiotherapy, immunotherapy, or other systemic antitumor treatment.\n* Human immunodeficiency virus infection, active hepatitis C virus infection, or hepatitis B virus infection with HBV DNA greater than 10\\^3\u002FmL.\n* History of pancreatitis or pancreatic disease considered unsuitable for pegaspargase treatment.\n* Acute or systemic infection requiring intravenous anti-infective treatment.\n* Severe complications including hemophagocytic lymphohistiocytosis or disseminated intravascular coagulation.\n* Significant organ dysfunction, including respiratory failure, chronic congestive heart failure of New York Heart Association class II or higher, decompensated hepatic or renal dysfunction, uncontrolled hypertension or diabetes despite appropriate treatment, or cardiovascular or cerebrovascular thrombosis or bleeding within the previous 6 months.\n* Active autoimmune disease or another condition considered by the investigator to make immune checkpoint inhibitor treatment unsuitable.\n* Pregnancy or breastfeeding.\n* Participants of reproductive potential who are unwilling to use adequate contraception.\n* Known severe hypersensitivity to any study drug or its excipients.\n* Another active malignancy within the previous 6 months requiring surgery, radiotherapy, or systemic anticancer therapy.\n* Severe psychiatric disorder, poor adherence, or another condition that, in the investigator's judgment, would prevent completion of protocol treatment or follow-up.\n* Current use of another investigational drug or participation in another interventional clinical trial within 4 weeks before enrollment.","ALL","18 Years","75 Years",{"count":20,"type":21},620,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This prospective, multicenter study evaluates a response-adapted treatment strategy for previously untreated patients with early-stage extranodal NK\u002FT-cell lymphoma of the upper aerodigestive tract.\n\nAll participants receive two cycles of GELAD induction chemotherapy, followed by early response assessment using positron emission tomography\u002Fcomputed tomography (PET\u002FCT) and plasma Epstein-Barr virus (EBV) DNA. Subsequent treatment is determined by the early response.\n\nParticipants with complete metabolic response and negative EBV DNA enter PART A and are randomized 1:1 to standard-dose radiotherapy (50 Gy) or reduced-dose radiotherapy (40 Gy); both groups subsequently receive two additional cycles of GELAD. Participants with partial response and negative EBV DNA enter PART B and receive standard 50 Gy radiotherapy followed by two additional cycles of GELAD. Participants with stable disease, local or regional progressive disease that remains amenable to curative radiotherapy, or partial response with positive EBV DNA enter PART C and receive 50 Gy radiotherapy followed by response-adapted sintilimab consolidation.\n\nThe primary objective of PART A is to determine whether reduced-dose radiotherapy is noninferior to standard-dose radiotherapy with respect to the 24-month progression-free survival rate. The primary objective of PART C is to evaluate the 24-month progression-free survival rate with response-adapted sintilimab consolidation in patients with a high-risk early response.",[27],"Natural Killer\u002FT-cell Lymphoma",[29,30,31,32,33,34,35,36,37],"Extranodal NK\u002FT-cell lymphoma","Early-stage NK\u002FT-cell lymphoma","GELAD","Response-adapted therapy","Radiotherapy de-escalation","Sintilimab","PD-1 blockade","PET\u002FCT","Epstein-Barr virus DNA","NOT_YET_RECRUITING","2026-08-12",{"date":41,"type":42},"2026-08-17","ACTUAL",{"date":44,"type":21},"2026-09-01",{"date":46,"type":21},"2036-06-30",{"name":48,"class":49},"Fudan University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100624402","multi-modal-fusion-model-and-deep-learning-for-predicting-treatment-response-in-nktcl-100624402","NCT07409168","Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NKTCL","Multi-modal Fusion Model and Deep Learning for Predicting Treatment Response in NK\u002FT-Cell Lymphoma","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years.\n* 2\\. Pathologically confirmed extranodal natural killer\u002FT-cell lymphoma (NKTCL) according to the World Health Organization (WHO) classification.\n* 3\\. Patients who are planned to receive first-line asparaginase-based chemotherapy or chemoradiotherapy.\n* 4\\. Patients who have either contrast-enhanced MRI of the nasopharynx obtained as part of routine clinical care or pretreatment whole-slide images (WSI) of tumor tissue from hematoxylin and eosin (H\\&E)-stained sections available for analysis.\n* 5\\. Ability to understand the study and provide written informed consent (ICF).\n\nExclusion Criteria:\n\n* 1\\. History of other malignant tumors.\n* 2\\. Patients with psychiatric disorders or those unable to provide informed consent.",{"count":59,"type":21},100,"OBSERVATIONAL","This is a multicenter prospective study to develop and validate a multimodal, deep learning-based model for predicting treatment response in patients with extranodal natural killer\u002FT-cell lymphoma (NKTCL) receiving first-line asparaginase-based therapy.",[27],"2026-04-26",{"date":65,"type":42},"2026-04-28",{"date":67,"type":21},"2026-08-15",{"date":69,"type":21},"2027-12-31",{"name":71,"class":49},"Sun Yat-sen University",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":50},"100622235","phase-2-pd-1-antibody-based-therapy-with-concurrent-rt-for-early-stage-nktcl-100622235","NCT07380984","PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL","A Prospective Study to Evaluate the Efficacy and Safety of PD-1 Monoclonal Antibody-based Stratified Targeted Therapy Combined With Concurrent Radiotherapy for Patients With Treatment-naive Early-stage Nasal-type NK\u002FT-cell Lymphoma","Inclusion Criteria:\n\n* The subject has histopathologically confirmed extranodal NK\u002FT-cell lymphoma, nasal type (according to the 2022 WHO classification).\n* No prior history of anti-lymphoma therapy.\n* Age ≥ 18 years.\n* Life expectancy \\> 3 months.\n* Ann Arbor stage I-II.\n* At least one measurable\u002Fevaluable disease site confirmed by diagnostic biopsy prior to the initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Signed informed consent form (ICF).\n* Willingness and ability to comply with the study protocol.\n* Sufficient bone marrow, hepatic, and renal function, defined as:\n\n  1. Absolute neutrophil count (ANC) \\> 1,000\u002FμL\n  2. Platelet count \\> 50,000\u002FμL\n  3. Hemoglobin \\> 9 g\u002FdL\n  4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3× upper limit of normal (ULN)\n  5. Serum total bilirubin \\\u003C 1.5 × ULN (patients with Gilbert's syndrome are eligible)\n  6. Serum creatinine \\\u003C 2 × ULN or creatinine clearance \\> 50 mL\u002Fmin\n* Availability of tumor tissue samples (preferably fresh tissue; archived tissue samples are acceptable).\n* For women of childbearing potential, agreement to use adequate contraception to avoid pregnancy during the study treatment period.\n* For male, agreement to remain abstinent or use a barrier method of contraception.\n\nExclusion Criteria:\n\n* Advanced-stage disease (Ann Arbor Stage III-IV).\n* Nonnasal-type NKTCL.\n* A history of autoimmune disease requiring systemic treatment (i.e., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within the past 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody-associated vasculopathy, granulomatosis with polyangiitis (Wegener's), Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\nThe following conditions are permissible for enrollment: patients with autoimmune hypothyroidism or type 1 diabetes receiving stable treatment; hormone replacement therapy (e.g., levothyroxine, insulin, or supplementation with physiological hormones for adrenal or pituitary insufficiency) is not considered systemic therapy and is allowed.\n\n* A history of other invasive malignancies within the past 3 years that has not been treated with curative intent or is currently receiving anticancer therapy (including hormonal therapy for breast or prostate cancer).\n* A history of (non-infectious) pneumonia requiring corticosteroid therapy; or clinical evidence of interstitial lung disease or active, non-infectious pneumonia.\n* Active infections requiring systemic treatment, including:\n\n  1. A known history of active tuberculosis;\n  2. Positive results for HBsAg, HCV, or HIV; HBV seropositivity is permitted only if HBV DNA \\\u003C 1000 IU\u002FmL;\n  3. Active viral infections other than hepatitis B and C (e.g., herpes zoster).\n* Severe cardiovascular disease, including myocardial infarction, unstable arrhythmia, or unstable angina occurring within the past 3 months.\n* Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.\n* Administration of live-attenuated vaccines within 4 weeks prior to the initiation of study treatment; patients are prohibited from receiving live-attenuated vaccines during the study period, including influenza vaccines.\n* Use of systemic immunosuppressive agents within 2 weeks prior to the initiation of study treatment, or planned use of such agents during the study period, including cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (anti-TNF) drugs.\n* Evidence of central nervous system involvement.\n* A history of allogeneic tissue\u002Fsolid organ transplantation.\n* A history of severe hypersensitivity reactions (Grade ≥ 3) to PD-1 monoclonal antibodies and\u002For their excipients, or to gorlitinib and\u002For its excipients.\n* Any other factors judged by the investigator to potentially affect compliance with the study protocol.",{"count":80,"type":21},47,[24],"Natural killer\u002FT-cell lymphoma (nasal type) is a mature T\u002FNK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal\u002Fparanasal regions, skin, gastrointestinal tract, and other organs. This study focuses on previously untreated patients with early-stage NKTCL (nasal type), exploring a response-adapted comprehensive therapeutic strategy that combines PD-1 monoclonal antibody-based stratified targeted therapy with concurrent radiotherapy. The aim is to provide integrated management for early-stage extranodal NK\u002FT-cell lymphoma (nasal type), and reduce toxicity while improving overall treatment outcomes for patients.",[27],"RECRUITING","2026-03-19",{"date":87,"type":42},"2026-03-20",{"date":89,"type":21},"2026-03",{"date":91,"type":21},"2029-02",{"name":93,"class":49},"Ruijin Hospital",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":50},"100590341","phase-1-a-phase-ibii-clinical-study-evaluating-the-safety-and-efficacy-of-tislelizumab-in-combination-with-golidocitinib-and-selinexor-for-the-treatment-of-rr-nktcl-100590341","NCT06966154","A Phase Ib\u002FII Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R\u002FR NKTCL","A Phase Ib\u002FII Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of Relapsed\u002FRefractory Natural Killer\u002FT-Cell Lymphoma (NKTCL)","Inclusion Criteria:\n\n* Voluntarily participate in the clinical study; fully understand and provide informed consent (via a signed Informed Consent Form, ICF); willing and able to comply with all trial procedures.\n* Histopathologically confirmed diagnosis of extranodal NK\u002FT-cell lymphoma, nasal type (NKTCL) by the participating study center.\n* Relapsed or refractory NKTCL after failure of asparaginase-based chemotherapy ± radiotherapy:\n\n  * Relapse: Disease recurrence \\>6 months after achieving complete response (CR) to prior therapy.\n  * Refractory: Failure to achieve CR or disease progression after adequate systemic therapy (≥4 cycles of a combination regimen).\n  * For Phase II: Patients must have received prior anti-PD-1 monoclonal antibody therapy and remain refractory.\n* At least one measurable or evaluable lesion per Lugano 2014 criteria:\n\n  * Measurable lesion: CT\u002FMRI: Longest diameter ≥1.5 cm (lymph nodes) or ≥1.0 cm (extranodal lesions).Post-radiation lesions require radiological evidence of progression.\n  * Evaluable lesion: FDG-PET: Lymph node\u002Fextranodal lesion with uptake \\> liver and imaging consistent with lymphoma.\n* Age ≥18 years at the time of ICF signing.\n* Life expectancy \\>12 weeks.\n* ECOG performance status 0-2.\n* Adequate organ and bone marrow function:\n\n  * Hematology (no transfusion\u002FG-CSF support within 14 days): ANC ≥1.5×10⁹\u002FL (≥0.5×10⁹\u002FL if bone marrow involvement)；Platelets ≥100×10⁹\u002FL (≥50×10⁹\u002FL if bone marrow involvement)；Hemoglobin ≥8.0 g\u002FdL.\n  * Liver function: Total bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome or liver involvement).\n\nALT\u002FAST ≤2.5×ULN (≤5.0×ULN with liver involvement).\n\n* Renal function: Serum creatinine ≤1.5×ULN OR creatinine clearance (Cockcroft-Gault) ≥50 mL\u002Fmin.\n* Coagulation: INR ≤1.5×ULN; PT\u002FAPTT ≤1.5×ULN (unless on anticoagulants within therapeutic range).\n* Cardiac function: LVEF ≥50% by echocardiography (ECHO).\n\n  * Recovery from prior anticancer therapy toxicities to CTCAE v5.0 Grade ≤1 or baseline. Exceptions: Irreversible Grade 2 toxicities unlikely to worsen during the study (e.g., neuropathy, alopecia) per investigator's assessment.\n  * For women of childbearing potential (WOCBP): Negative serum pregnancy test within 7 days before enrollment. WOCBP and male participants with WOCBP partners must agree to use effective contraception from ICF signing until ≥6 months after the last study dose.\n\nExclusion Criteria:\n\n* History of malignancy within the past 5 years, with the exception of: Locally curable malignancies treated with curative intent (e.g., basal or squamous cell skin cancer, thyroid carcinoma, superficial bladder cancer, or in situ carcinoma of the prostate, cervix, or breast).\n* Any of the following prior treatments:\n\n  * History of allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 5 years prior to the first dose (patients with allo-HSCT \\>5 years before the first dose and no active graft-versus-host disease may enroll).\n  * Autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.\n  * Prior use of JAK inhibitors, STAT3 inhibitors, or XPO1 inhibitors.\n  * Current use of vitamin K antagonists, antiplatelet agents, or anticoagulants (or inability to discontinue within 1 week before the first dose).\n  * Systemic glucocorticoids or immunosuppressants within 14 days prior to enrollment (allowed: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoids; short-term \\[≤7 days\\] prophylactic use for non-autoimmune conditions).\n  * Cytotoxic chemotherapy within 14 days prior to enrollment.\n  * Systemic anticancer therapy (including monoclonal antibodies or immunotherapy) within 4 weeks prior to the first dose.\n  * Major organ surgery within 6 weeks or radiotherapy within 90 days prior to enrollment.\n  * Radioimmunoconjugate therapy within 10 weeks prior to enrollment.\n  * Use of other investigational drugs requiring investigator's risk-benefit assessment.\n  * Participation in other clinical trials with investigational drugs within 30 days prior to enrollment.\n  * Vaccines (except influenza vaccines) within 28 days prior to enrollment.\n* Active infections, including:\n\n  * Active or latent tuberculosis (positive tuberculin skin test \\[PPD\\] with induration ≥10 mm or radiologically confirmed active lesions).\n  * Known HIV infection or AIDS.\n  * Chronic active hepatitis B or C:\n\nHBV: Exclude if HBV DNA detectable (↑center-specific ULN). HCV: Exclude if HCV RNA detectable (↑center-specific ULN).\n\n* Other active viral infections (e.g., herpes zoster, CMV) requiring treatment. Infections requiring intravenous antimicrobial therapy.\n\n  * Uncontrolled cardiac conditions, including:\n* NYHA Class \\>II heart failure.\n* Unstable angina.\n* Myocardial infarction within 1 year.\n* Clinically significant arrhythmias requiring intervention.\n\n  * Persistent drug-related toxicities \\>CTCAE Grade 1 (excluding alopecia) at baseline.\n  * Uncontrolled nausea\u002Fvomiting, chronic gastrointestinal diseases, dysphagia, or prior bowel resection affecting drug absorption.\n  * Pregnancy, lactation, or refusal to use contraception by participants of reproductive potential.\n  * Psychiatric disorders or inability to provide informed consent.\n  * Other conditions deemed unsuitable for study participation by the investigator.",{"count":102,"type":21},68,[104,24],"PHASE1","This open-label, multicenter Ib\u002FII phase clinical trial investigates the safety, tolerability, and preliminary efficacy of tislezumab (anti-PD-1 monoclonal antibody), golidocitinib (JAK1\u002FSTAT3 signaling pathway inhibitor), and selinexor (selective inhibitor of nuclear export, XPO1 antagonist) in patients with relapsed\u002Frefractory extranodal natural killer\u002FT-cell lymphoma (R\u002FR ENKTL) progressing after ≥1 line of L-asparaginase-containing chemotherapy or chemoradiotherapy.",[27,107],"Relapsed or Refractory Lymphoma Including ENKL",[109,110,111,112,113],"natural killer\u002FT-cell lymphoma","Immune checkpointor inhibitor","tislelizumab","golidocitinib","selinexor","2025-05-26",{"date":116,"type":42},"2025-05-30",{"date":114,"type":42},{"date":119,"type":21},"2028-05-30",{"name":48,"class":49}]