[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rong Tao\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":134},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,107],{"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":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":48},"100631948","phase-2-chidamide-maintenance-for-mrd-positive-double-expressor-dlbcl-in-first-complete-remission-100631948","NCT07507318","Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission","A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive","DEL-MRD-CHID","Inclusion Criteria:\n\n* Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.\n* Double-expressor lymphoma confirmed by pathology, defined as MYC expression \\>=40% and BCL2 expression \\>=50% by immunohistochemistry.\n* Complete response after initial induction therapy.\n* Age \\>=18 and \\\u003C=80 years.\n* ECOG performance status 0-2.\n* No prior history of malignant tumor and no concurrent malignancy.\n* International Prognostic Index (IPI) score \\>1.\n* ctDNA MRD-positive at screening\u002Fenrollment.\n* Life expectancy of at least 6 months, in the opinion of the investigator.\n* Written informed consent provided before any study-specific procedure.\n\nExclusion Criteria:\n\n* Failure to achieve complete response after initial induction therapy.\n* Prior organ transplantation.\n* Uncontrolled coagulopathy or active bleeding.\n* Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction \\\u003C50%, connective tissue disease, or severe active infection.\n* Major organ surgery within 6 weeks before screening.\n* Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \\\u003C1.5 x 10\\^9\u002FL; platelet count \\\u003C80 x 10\\^9\u002FL (or \\\u003C50 x 10\\^9\u002FL in patients with bone marrow involvement); total bilirubin \\>1.5 x upper limit of normal; ALT\u002FAST \\>2.5 x upper limit of normal, or \\>5 x upper limit of normal in patients with hepatic involvement; serum creatinine \\>1.5 x upper limit of normal.\n* Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.\n* HIV infection.\n* Ongoing antitumor therapy for lymphoma or another malignancy.\n* Drug abuse or chronic alcohol abuse that may interfere with study evaluation.\n* Psychiatric illness or any condition resulting in inability to comply with the protocol.\n* Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.\n* Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial\u002Fcomplete bowel obstruction.\n* Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.","80 Years",{"count":59,"type":22},69,[61],"PHASE2","This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.",[64],"Diffuse Large B-Cell Lymphoma",[66,67,68,69,70],"Chidamide","Tucidinostat","Minimal Residual Disease","Maintenance Therapy","Double-Expressor Lymphoma","RECRUITING","2026-06-16",{"date":74,"type":41},"2026-06-18",{"date":72,"type":41},{"date":77,"type":22},"2029-06-30",{"name":46,"class":47},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"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":88,"type":22},107,[90,61],"PHASE1","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.",[28,93,94],"NK\u002FT-cell Lymphoma","Relapsed or Refractory NK\u002FT-Cell Lymphoma",[96,97,98,99,100],"Tislelizumab","Zeprumetostat","EZH2 inhibitor","PD-1 inhibitor","NKTCL",{"date":74,"type":41},{"date":103,"type":41},"2026-04-30",{"date":105,"type":22},"2028-12-30",{"name":46,"class":47},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100550340","phase-1-cd19cd22-car-t-cells-in-adults-with-rr-all-or-nhl-100550340","NCT06445803","CD19\u002FCD22 CAR-T Cells in Adults With R\u002FR ALL or NHL","A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19\u002FCD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Male or female,≥18 years old;\n* Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):\n\n(B-NHL)\n\n1. Second or greater relapse (CD20 regimens must be included) OR\n2. Refractory to first-line chemotherapy or relapse within 1 year OR\n3. Relapse within 1 year of auto-HSCT.\n4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)\n\na. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR\u002FCRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.\n\n* ECOG 0\\~2\n* Estimated survival time ≥ 12 weeks;\n* Main tissues and organs function well.\n\nExclusion Criteria:\n\n* Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg\u002Fd or equivalent) within 72 h\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；\n* active bleeding, or venous thromboembolic event\n* Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs\n* Central nervous system (CNS) disease or symptoms of CNS involvement\n* Pregnant or nursing (lactating) women\n* Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded\n* Any Iinappropriate conditions in the opinion of the PI .",{"count":115,"type":22},48,[90],"This study examines the safety, tolerability and preliminary efficacy of anti-CD19 \u002FCD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.",[119,120,121,122],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia With Failed Remission","B-cell Lymphoma Refractory","B-cell Lymphoma Recurrent",[124],"CAR-T therapy","2024-06-01",{"date":127,"type":41},"2024-06-06",{"date":129,"type":41},"2024-05-31",{"date":131,"type":22},"2026-12",{"name":46,"class":47},2,""]