[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mingzhi Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,73],{"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":27,"conditions":28,"keywords":30,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100559086","phase-1-selinexorpegaspargasedexamethasonein--nktcl-100559086",false,"NCT06559553","\"Selinexor+Pegaspargase+Dexamethasone\"in Ⅰ\u002FⅡ NKTCL","A Prospective Clinical Study of \"Selinexor+Pegaspargase+Dexamethasone\" in the Treatment of Stage Ⅰ\u002FⅡ NK\u002F T-Cell Lymphoma","Selinexor","Inclusion Criteria:\n\n1. Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);\n2. Pre-survival time \\> 6 months;\n3. The pathological tissue was confirmed as NK\u002FT cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic third-party consultation could be organized);\n4. Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;\n5. Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10\\^9 \u002FL, platelet ≥75×10\\^9 \u002FL, hemoglobin ≥80g\u002FL (except patients with lymphoma bone marrow infiltration);\n6. Liver function: direct bilirubin ≤1.5× upper limit reference value; Glutamic pyruvic transaminase or glutamic oxalacetic transaminase ≤2.5× upper limit reference value; Alkaline phosphatase ≤3×ULN in non-bone invaded patients;\n7. Renal function: serum creatinine ≤1.5×ULN;\n8. Female and male patients of reproductive age and their spouses are willing to use adequate contraception throughout the study period, and female patients of reproductive age must have a negative serum pregnancy test within 7 days before the first dose;\n9. The newly treated patient had not received other tumor-related treatment in the past;\n10. Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;\n\nExclusion Criteria:\n\n1. Refuse to collect blood samples;\n2. Previous allergy to any of the drugs in the program;\n3. Pregnant and lactating women;\n4. Major diseases that the investigator believes can cause interference with the test;\n5. Combined with other tumors;\n6. There are contraindications related to therapeutic drugs in the program;\n7. Persons with serious mental illness;\n8. Participating in other clinical trials;\n9. Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);\n10. Other serious medical conditions that may limit participants\\' participation in the trial, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome within the last 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related procedures within the last 6 months; Severe arrhythmias include frequent ventricular early, ventricular tachycardia, rapid atrial fibrillation\u002Fflutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure \\>150mmHg, diastolic blood pressure \\>100mmHg. Gastric ulcers (stomach ulcers that researchers have determined are at risk of perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren\\'s syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory disease (such as obstructive pulmonary disease and a history of bronchospasm);\n11. Hemophagic cell syndrome;\n12. Researchers do not consider it suitable for inclusion;\n13. Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive.","ALL","18 Years","70 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","evaluate the efficacy and safety of \"Selinexor+pegaspargase+dexamethasone\" in early stage NK\u002F T-cell lymphoma",[29,15],"NKTCL",[29,15],"RECRUITING","2025-07-10",{"date":34,"type":35},"2025-07-14","ACTUAL",{"date":37,"type":35},"2024-09-01",{"date":39,"type":22},"2026-12-31",{"name":41,"class":42},"Mingzhi Zhang","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":43},"100568642","phase-1-a-prospective-clinical-study-of-the-combination-therapy-of-obutinib-or-decitabine-with-rituximab-cyclophosphamide-and-prednisone-for-the-primary-treatment-of-elderly-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100568642","NCT06683885","A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender;\n2. ECOG 0-1； IPI score ≤ 3 points;\n3. Expected survival period of more than 3 months;\n4. DLBCL diagnosed by tissue biopsy pathology;\n5. No contraindications for chemotherapy (blood and physiological examination results within 7 days), absolute neutrophil count ≥ 1.0 × 10 \\^ 9\u002FL, PLT ≥ 75 × 10 \\^ 9\u002FL, hemoglobin ≥ 80g\u002FL (excluding patients with lymphoma bone marrow infiltration);\n6. According to the RECIST criteria, there must be at least one measurable lesion. For intranodal lesions, it is defined as: long diameter ≥ 1.5cm and short diameter ≥ 1.0cm; For extranodal lesions, the length and diameter should be ≥ 1.0cm;\n7. Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN;\n8. Renal function: serum creatinine ≤ 1.5 × ULN;\n9. No other serious illnesses that conflict with this plan;\n10. Excluding other major illnesses, the heart function is normal;\n11. There are no other related treatments including traditional Chinese medicine (anti-tumor effects), immunotherapy, or biologic therapy (except for treatment of bone metastasis and other symptoms);\n12. The subjects voluntarily participate in the clinical trial, sign an informed consent form, and cooperate with follow-up;\n13. During this treatment period, if other anti-tumor drugs are not used simultaneously, bisphosphonates can be used for bone metastasis treatment and other symptomatic treatments;\n\nExclusion Criteria:\n\n1. Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be quit, or other substantial lesions that may increase central neurotoxicity;\n2. Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of enrollment (excluding those who have not received treatment);\n3. Systemic autoimmune diseases or immunodeficiency;\n4. Refusing to collect blood samples;\n5. Allergic to any medication in the plan;\n6. Pregnant and lactating women;\n7. Major diseases that can cause experimental interference and uncontrolled active infections;\n8. Primary or secondary central tumors;\n9. Chemotherapy contraindications;\n10. Within 28 days of using Rituximab\u002FObutinib\u002FCompound Cyclophosphamide Tablets\u002FAzacitidine;\n11. Researchers believe that it is not suitable for inclusion;\n12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed skin fungal infections) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within the 4 weeks prior to enrollment (excluding tumor fever);\n13. Apply other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);\n14. Other serious diseases that may restrict the subjects from participating in the test, such as uncontrollable diabetes; Severe heart failure (NYHA grade II or above); Acute coronary syndrome has occurred within the past 6 months; Coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel related surgeries within the past 6 months; Severe arrhythmias include frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation\u002Fflutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure\\>150mmHg, diastolic blood pressure\\>100mmHg. Gastric ulcer (determined by researchers to have a risk of perforation); Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc;\n15. Individuals with bloodthirsty cell syndrome;\n16. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive hepatitis C virus (HCV) RNA in peripheral blood; Individuals who are HIV antibody positive; Individuals who test positive for Cytomegalovirus (CMV) DNA; Individuals who test positive for syphilis.","65 Years",{"count":52,"type":22},80,[25,26],"A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma",[56],"Newly Diagnosed Diffuse Large B-cell Lymphoma",[58,59,60,61,62,63,64],"DLBCL","clinical trial","chemotherapy","PFS","ORR","Obutinib","Decitabine","2024-11-08",{"date":67,"type":35},"2024-11-12",{"date":69,"type":22},"2024-11-20",{"date":71,"type":22},"2026-05-01",{"name":41,"class":42},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":100,"locationsCount":43},"100565834","phase-1-car-t-technology-for-recurrentrefractory-malignant-hematological-and-lymphatic-tumors-100565834","NCT06647329","CAR-T Technology for Recurrent\u002FRefractory Malignant Hematological and Lymphatic Tumors","CAR-T Technology for the Treatment of Recurrent\u002FRefractory Malignant Hematological and Lymphatic Tumors: Multi-Center Clinical Study on Safety and Efficacy","CAR-T Therapy","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following conditions to be included:\n\n1. The participant has given informed consent and signed the consent form, and is willing and capable of complying with the scheduled visits, study treatment, laboratory examinations, and other trial procedures.\n2. Clinically diagnosed as having relapsed\u002Frefractory malignant hematologic tumors:\n\n   2.1 Diagnosed as CD19+ and\u002For CD20+ and\u002For CD22+ B-cell tumors through pathological and histological examinations, and the participant meets the criteria for relapsed or refractory B-cell malignancies as follows:\n\n   B-cell tumors include the following three categories:\n\n   A. B-cell acute lymphoblastic leukemia (B-ALL); B. Indolent B-cell lymphomas (CLL, FL, MZL, LPL, HCL); C. Aggressive B-cell lymphomas (DLBCL, BL, MCL).\n\n   2.1.1. Refractory\u002Frelapsed B-cell leukemia (meeting one of the following four criteria): A. Relapse within 6 months after initial remission; B. Initial refractory after 2 cycles of standard chemotherapy without achieving complete remission; C. Relapse or refractory after first-line or multi-line salvage chemotherapy without achieving complete remission; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation.\n\n   2.1.2. Refractory\u002Frelapsed B-cell lymphoma (meeting one of the first four criteria plus the fifth): A. Tumor shrinkage of less than 50% or disease progression after 4 cycles of standard chemotherapy; B. Achieved CR after standard chemotherapy, but relapsed within 6 months; C. Relapsed 2 times or more after achieving CR; D. Not suitable for hematopoietic stem cell transplantation, or have abandoned transplantation due to conditions, or relapse after transplantation;\n\n   E. The participant must have received sufficient prior treatment, including at least:\n   1. Anti-CD20 monoclonal antibodies\n   2. Combination chemotherapy containing anthracyclines.\n\n   2.2 Refractory\u002Frelapsed multiple myeloma: Progressed after at least 3 lines of treatment (at least one proteasome inhibitor and one immunomodulator used).\n\n   2.3 Presence of measurable or evaluable lesions: A. For lymphoma patients, a single lesion ≥15 mm or two or more lesions ≥10 mm, or PET-positive lesions determined according to Lugano criteria; B. For leukemia and myeloma patients, bone marrow MRD must be persistently positive or positive relapse.\n3. Age 14-75 years (inclusive), both male and female.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. Treatment-related antigen test results must be positive:\n\n   A. For lymphoma: CD19\u002FCD20\u002FCD22 (immunohistochemical results positive within six months); B. For acute lymphoblastic leukemia: CD19\u002FCD22 (tumor cells detected positive by flow cytometry in bone marrow at screening, or extramedullary lesions with positive immunohistochemistry results within six months); C.For multiple myeloma: BCMA (tumor cells detected positive by flow cytometry in bone marrow at screening, or extramedullary lesions with positive immunohistochemistry results within six months).\n6. Expected survival time greater than 3 months from the date of signing the informed consent form.\n7. HGB ≥ 70 g\u002FL (transfusion allowed).\n8. Liver and kidney function, and cardiopulmonary function must meet the following requirements: a) Creatinine ≤ 1.5 × ULN; b) Left ventricular ejection fraction ≥ 50%; c) Blood oxygen saturation \\> 90%; d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.\n9. Participants with a plan for pregnancy must agree to use contraception before enrollment and for six months after the study begins; if the participant becomes pregnant or suspects pregnancy, they must immediately notify the investigator.\n\nExclusion Criteria:\n\nParticipants who meet any of the following conditions are not eligible for inclusion:\n\n1. History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) class III or IV heart failure, cardiovascular intervention (angioplasty or stenting), myocardial infarction, unstable angina, or other clinically significant heart diseases.\n2. History of severe pulmonary dysfunction.\n3. Concurrent advanced malignant tumors.\n4. Concurrent systemic fungal, bacterial, viral, or other infections that cannot be effectively controlled.\n5. Concurrent severe autoimmune diseases or congenital immunodeficiency.\n6. Active hepatitis (positive HBV DNA or HCV RNA testing).\n7. Human Immunodeficiency Virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.\n8. History of severe allergic reactions to biologics (including antibiotics).\n9. Less than 6 months since undergoing allogeneic hematopoietic stem cell transplantation.\n10. Acute or chronic graft-versus-host disease (GvHD).\n11. History of deep vein thrombosis (DVT) (cancer-related thrombosis) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.\n12. Anticoagulation treatment for DVT or PE within 3 months prior to signing the informed consent form.\n13. History or clinical significance of CNS diseases at screening, such as epilepsy, seizure disorders, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or mental disorders.\n14. Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphocyte-depleting chemotherapy.\n15. Use of any of the following medications or treatments within the specified time before leukapheresis:\n\n    A. Use of alemtuzumab within the past 6 months prior to leukapheresis; B. Use of anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis; C. Use of Venetoclax within 4 days prior to leukapheresis; D. Use of lenalidomide within 3 days prior to leukapheresis; E. Use of Idelalisib within 2 days prior to leukapheresis; F. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\> 20 mg\u002Fday) within 7 days prior to leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted; G. Use of investigational drugs within 4 weeks prior to leukapheresis. However, if treatment was ineffective or the disease progressed during the trial and at least 3 half-lives have elapsed before leukapheresis, enrollment is allowed; H. Received donor lymphocyte infusion (DLI) within 6 weeks prior to CAR-T administration.\n16. Any factors judged by the investigator that may affect compliance with the study protocol, including uncontrollable medical, psychological, familial, sociological, or geographical factors, or unwillingness or inability to comply with the required procedures of the study protocol.","14 Years","75 Years",{"count":84,"type":22},30,[25],"evaluate the safety and Esfficacy of CAR-T technology for the treatment of recurrent\u002Frefractory malignant hematological lymphomas",[88,89],"CAR-T Cell Therapy","Lymphomas",[91,92],"CAR-T therapy","Recurrent\u002FRefractory Malignant Hematological Lymphomas","NOT_YET_RECRUITING","2024-10-16",{"date":96,"type":35},"2024-10-17",{"date":98,"type":22},"2024-12-01",{"date":39,"type":22},{"name":41,"class":42},""]