[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Li Zhiming\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,71,99],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100610720","phase-2-glofitamab-plus-polatuzumab-vedotin-and-zuberitamab-in-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100610720",false,"NCT07231250","Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma","Glofitamab Plus Polatuzumab Vedotin and Zuberitamab in Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma: A Multicenter Phase II Study","Inclusion Criteria:\n\n* The following criteria must be met to be eligible for the study:\n\n  1. Written informed consent.\n  2. Age ≥18 years at the time of signing the Informed Consent Form\n  3. IPI score 2-5.\n  4. ECOG performance status of 0-2.\n  5. Histologically confirmed CD20-positive LBCL, including one of the following diagnoses by 2022 WHO classification of lymphoid neoplasms:\n* DLBCL, not otherwise specified (NOS) including germinal B-cell type, activated B-cell type\n* T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n* Epstein-Barr virus-positive DLBCL, NOS\n* Anaplastic lymphoma kinasepositive large B-cell lymphoma\n* Kaposi's sarcomaassociated herpesvirus\u002Fhuman herpesvirus-8positive DLBCL\n* DLBCL\u002FHGBCL with MYC and BCL2 rearrangements\n* HGBCL, NOS. (6) At least one measurable site of disease (\\>1.5 cm long axis). (7) No previous treatment for lymphoma. (8) Life expectancy ≥6 months. (9) Left ventricular ejection fraction (LVEF) ≥50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) (10) Patient has adequate liver function:\n\n  * Total bilirubin ≤1.5 x ULN (≤3 x ULN in patients with Gilbert's syndrome).\n  * AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤3 x ULN.\n\n    o Patients with documented liver involvement: AST and\u002For ALT ≤5 x ULN. (11) Patient has adequate hematological function, unless due to lymphoma:\n  * Hemoglobin ≥9.0 g\u002FdL within 7 days before the first treatment.\n  * Absolute neutrophil count of ≥1.0 x 109 cells\u002FL (1,000\u002FμL).\n  * Platelet count of ≥75 x 109 cells\u002FL (75,000\u002FμL). Note: Transfusion of RBCs and platelets is allowed to reach the inclusion criteria. In case screening procedures are leading to situations that would exclude the patient from study participation (such as Hb value below entry criteria), the patient may still be enrolled into the trial after consultation with the principal investigator.\n\n    (12) Patient has adequate renal function:\n  * Creatinine ≤ 1.5 x ULN, or Creatinine clearance (CrCl) calculated by Cockcroft-Gault formula of ≥ 30 mL\u002Fmin for patients in whom, in the Investigator's judgment, serum creatinine levels do not adequately reflect renal function.\n\nExclusion Criteria:\n\n* Patients who meet at least one of the following criteria are not eligible for trial participation:\n\n  1. History of severe cardiac disease: New York Heart Association (NYHA) grade 3-4, congestive heart failure, myocardial infarction or cerebrovascular accident within the past 3 months, unstable arrhythmias, or unstable angina or history of multiple cardiovascular events) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm).\n\n     Note: Congestive heart failure NYHA II patients can be included if they provide an LVEF \\> 40%.\n  2. Patient with current or history of CNS lymphoma.\n  3. Patient with uncontrolled severe infection, whether bacterial (e.g., tuberculosis), viral (including, but not limited to severe pneumonia, COVID-19, Epstein-Barr virus \\[EBV\\], cytomegalovirus \\[CMV\\], hepatitis B, hepatitis C, and HIV\\], fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks prior to study enrollment.\n\n     Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n  4. Patient with current \\> Grade 1 peripheral neuropathy.\n  5. Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment\n  6. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.\n  7. Known hypersensitivity to hamster ovary (CHO) cell products or to any component of the Zuberitamab, polatuzumab vedotin, obinutuzumab, or glofitamab and\u002For to the contrast agents used in the study.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.",[26,27,28],"DLBCL - Diffuse Large B Cell Lymphoma","Chemo-free Therapy","Bispecific Antibody","NOT_YET_RECRUITING","2025-11-15",{"date":32,"type":33},"2025-11-19","ACTUAL",{"date":35,"type":20},"2026-01-15",{"date":37,"type":20},"2028-09-15",{"name":39,"class":40},"Li Zhiming","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100591826","phase-2-orelabrutinib-combined-with-zuberitamab-in-the-initial-treatment-of-mzl-100591826","NCT06985472","Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL","Orelabrutinib Combined With Zuberitamab in the Initial Treatment of MZL Single-arm, Multicenter Phase II Clinical Study","ZOOM","Inclusion Criteria:\n\n1\\. Age 18 years or older; 2. ECOG performance status (PS) level 0\\~2; 3. The expected survival is not less than 12 weeks; 4. CD20-positive marginal area lymphoma confirmed according to WHO2008 lymphoma classification standard, including splenic MZL, lymph node MZL and extranodal MZL subtypes; 5. MZL with stage III\u002FIV disease and stage I\u002FII disease recurrence or progression after local treatment can also be included, and patients who have received BTKi inhibitor therapy for more than 6 months can also be included; 6. Enhanced computerized tomography\u002Fmagnetic resonance imaging (CT\u002FMRI) to detect measurable lesions; 7. Indications for MZL treatment that meet NCCN guidelines and have not received systematic treatment for MZL in the past (anti-infective treatment such as anti-HP and HCV is not systemic treatment); 8. The main organ function is normal and meet the following criteria :\n\n1. blood routine examination standards must meet:\n\n   1. ANC\\>1.0×109\u002FL;\n   2. PLT\\>75×109\u002FL (≥50×109\u002FL for patients with confirmed bone marrow infiltration);\n   3. Hb\\>80g\u002FdL;\n2. Biochemical examination should meet the following criteria :\n\n   1. TBIL\\\u003C2×ULN;\n   2. ALT and AST\\\u003C2.5XULN(for patients with liver invasion,ALT and AST\\\u003C5×ULN);\n   3. Endogenous creatinine clearance ≥40ml\u002Fmin (Cockcroft-Gault formula). 9. Women of childbearing age must have been using reliable contraception or had a pregnancy test (serum or urine) within 7 days of enrol with a negative result and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last dose of the trial drug; 10. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.\n\n      \\-\n\n      Exclusion Criteria:\n      1. Patients with central nervous system invasion;\n      2. Previous or co-existing uncured malignancies, except cured skin basal cell MZL clinical trial protocol cancer, cervical carcinoma in situ and superficial bladder cancer;\n      3. Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval 2450 ms for men and 2470 ms for women); According to NYHA standards, patients with grade III to V cardiac insufficiency or left ventricular ejection fraction (LVEF) \\\u003C50% indicated by cardiac color ultrasound;\n      4. Abnormal coagulation function (INR\\>1.5 or prothrombin time (PT) \\>ULN+4 seconds or APTT \\>1.5 ULN), have a tendency to hemorrhage or are receiving thrombolytic or anticoagulant therapy;\n      5. Arteriovenous thrombosis events occurring in the 12 months prior to enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n      6. The presence of known hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophiliac, coagulation disorder, thrombocytopenia, hypersplenism, etc.);\n      7. Had major surgery or severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;\n      8. Have significant factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;\n      9. Active infections that require antimicrobial treatment (such as antimicrobial drugs, antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment, antifungal drug treatment);\n      10. Active hepatitis B (HBV DNA\\>2000IU\u002FmL or 104 copy numbers \u002FmL) or hepatitis C (hepatitis C antibody positive with HCVRNA higher than the lower detection limit of analytical methods);\n      11. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n      12. Had participated in other anti-tumor drug clinical trials within 4 weeks before enrollment;\n      13. Patients who had received potent CYP3A4 inhibitors within 7 days before enrollment, or had received potent CYP3A4 inducers within 12MZL clinical trial regimen days before enrollment;\n      14. Pregnant or lactating women; A fertile patient who is unwilling or unable to take effective contraceptive measures;\n      15. The investigator determines other circumstances that may affect the conduct of the clinical study and the determination of the study results.",{"count":51,"type":20},33,[23],"This is a multi-center, prospective cohort study. The main purpose of study is to evaluate the efficacy and safety of Orelabrutinib combined with Zuberitamab in the initial treatment of MZL Main efficacy indicators Complete response rate (CR) at the end of combination therapy.",[55,56,57,58],"Initial MZL","Untreated MZL","BTKi","CD20",[60],"Orelabrutinib combined with Zuberitamab in the initial treatment of MZL","RECRUITING","2025-05-14",{"date":64,"type":33},"2025-05-22",{"date":66,"type":33},"2024-11-13",{"date":68,"type":20},"2027-12-31",{"name":39,"class":40},2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},"100584533","phase-2-zanubrutinib-chidamide-and-rituximab-induction-with-or-without-chop-versus-r-chop-in-newly-diagnosed-double-expressor-dlbcl-100584533","NCT06890585","Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL","A Randomized, Multicenter, Open-Label Phase II Clinical Study Comparing the Efficacy and Safety of Zanubrutinib, Chidamide, and Rituximab Induction Therapy Sequentially Combined With or Without CHOP Versus R-CHOP in the First-Line Treatment of Patients With Newly Diagnosed Double-Expressor Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Newly diagnosed MYC\u002FBCL2 double-expressor DLBCL confirmed by pathological histology\u002Fclinical imaging, with IHC BCL2 expression ≥50% and MYC expression ≥40%.\n* Male or female patients aged 18-65 years.\n* ECOG score of 0-2.\n* Expected survival time of ≥6 months.\n* Must have at least one evaluable or measurable lesion according to the Lugano 2014 criteria \\[Evaluable lesion: lymph node or extranodal local uptake increased (higher than the liver) on 18F-Fluorodeoxyglucose\u002FPositron Emission Tomography (18FDG\u002FPET) scan, and PET and\u002For Computed Tomography (CT) features consistent with lymphoma; Measurable lesion: nodal lesion with a long diameter \\>15mm or extranodal lesion with a long diameter \\>10mm, with increased 18FDG uptake\\]. Patients with no measurable lesions and diffuse 18FDG uptake in the liver should be excluded.\n* Good major organ function, meeting the following requirements within one week before enrollment: blood routine WBC ≥3×10\\^9\u002FL, Hb ≥80g\u002FL, PLT ≥80×10\\^9\u002FL; normal cardiac and liver function (total bilirubin ≤1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal), normal renal function (serum creatinine ≤1.5 times the upper limit of normal), and no coagulation abnormalities.\n* LVEF ≥50% as measured by echocardiography.\n* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be willing to use reliable contraception during the study.\n* Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Special types of DLBCL:Fluid overload-associated large B-cell lymphoma, primary mediastinal large B-cell lymphoma, mediastinal gray zone lymphoma, primary central nervous system (CNS) DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements.\n* Transformed DLBCL (e.g., DLBCL transformed from follicular lymphoma, chronic lymphocytic leukemia\u002Fsmall B-cell lymphoma), secondary CNS involvement of DLBCL.\n* History of other malignancies within the past 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, and carcinoma in situ of the cervix.\n* Major surgery within the past 2 months (excluding diagnostic surgery).\n* Previous treatment for NHL, including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy, or surgical treatment (excluding diagnostic surgery and biopsy).\n* Previous treatment with cytotoxic drugs or anti-CD20 monoclonal antibody therapy for other diseases (e.g., rheumatoid arthritis).\n* Use of any monoclonal antibody within 3 months prior to enrollment, participation in other clinical trials with investigational drugs, or vaccination with live attenuated virus vaccines within 1 month prior to enrollment.\n* Use of hematopoietic growth factors within 2 weeks prior to enrollment.\n* Suspected active or latent tuberculosis.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed fungal infections) within 4 weeks prior to enrollment, or any major systemic infection requiring intravenous antibiotics or hospitalization (excluding tumor fever).\n* History of severe bleeding disorders, such as hemophilia A, hemophilia B, von Willebrand disease, or spontaneous bleeding requiring transfusion or other medical intervention.\n* HIV-positive patients. Active HBV-positive and HCV-positive patients, but those with controlled conditions as judged by the investigator may be cautiously enrolled with effective antiviral intervention.\n* Other severe diseases that may limit participation in this trial, such as uncontrolled diabetes; severe heart failure (NYHA class II or above); acute coronary syndrome within the past 6 months; coronary revascularization within the past 6 months, such as stent implantation, coronary artery bypass grafting, and other heart and large vessel surgeries; severe arrhythmias including frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation\u002Fflutter, severe bradycardia. Uncontrolled hypertension (greater than 150\u002F100 mmHg). Gastric ulcer (with a risk of perforation as judged by the investigator); active autoimmune diseases; severe hypertension; severe respiratory diseases (e.g., obstructive pulmonary disease and bronchospasm history), such as known interstitial pneumonia or highly suspected interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Contraindications to any study drug, including previous treatment with anthracyclines; patients with diabetes who cannot tolerate prednisone treatment in this regimen.\n* History of alcohol abuse or drug abuse.\n* Allergic constitution, or known allergy to any active ingredient, excipient, or murine products, heterologous proteins included in this study.\n* Requirement for continuous treatment with strong CYP3A inhibitors or inducers (see Appendix 6).\n* Severe mental illness.\n* Patients unable to comply with the study and\u002For follow-up phases.\n* Patients unable to swallow study drugs normally.\n* Patients deemed unsuitable for enrollment by the investigator.","65 Years",{"count":80,"type":20},128,[23],"Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies, which make it a promising regimen for B cell lymphoma. Chidamide is an oral subtype-selective histone deacetylase inhibitor.\n\nThis Randomized, Multicenter, Open-Label Phase II Clinical Study is comparing the efficacy and safety of Zanubrutinib, Chidamide, and Rituximab induction therapy sequentially combined with or without CHOP versus R-CHOP in the first-line treatment of patients with newly diagnosed double-expressor DLBCL.",[84,85,86],"BTK Inhibitors","Histone Deacetylase Inhibitor","Double Express Diffuse Large B-cell Lymphoma",[88,89,90],"Double Expressor Diffuse Large B-cell Lymphoma","zanubrutinib","chidamide","2025-03-17",{"date":93,"type":33},"2025-03-24",{"date":95,"type":20},"2025-06-01",{"date":97,"type":20},"2029-12-31",{"name":39,"class":40},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},"100471683","phase-2-selinexor-plus-r-chop-in-high-risk-gcb-subtype-diffuse-large-b-cell-lymphoma-100471683","NCT05422066","Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma","Frontline Selinexor(ATG-010) Plus R-CHOP Therapy for High-risk GCB-subtype Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:\n\n  1. Willing and able to written informed consent (ICF) .\n  2. Age ≥ 18 years and ≤ 75 years.\n  3. Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.\n  4. Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.\n  5. International Prognostic Index score of 3-5.\n  6. Computed Tomography(CT)\u002FPositron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than \\> 1.5cm or 1 extranodal lesion with LDi \\>1 cm.\n  7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n  8. Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).\n\n     1. Absolute neutrophil count (ANC)≥1.5×109\u002FL;\n     2. Platelet count (PLT) ≥100×109\u002FL(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109\u002FL if due to lymphoma with bone marrow involvement.\n     3. Hemoglobin (HB)≥85g\u002FL(no red blood cell transfusion within 14 days prior to C1D1).\n  9. Adequate hepatic and renal function:\n\n     1. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),\n     2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.\n     3. Estimated creatinine clearance ≥ 30 mL\u002Fmin (calculated using the formula of Cockroft-Gault).\n  10. Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.\n\n      1. Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\n      2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.\n\nExclusion Criteria:\n\n* Inclusion\u002FExclusion Criteria:\n\nInclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be eligible to enroll in this study:\n\n1. Willing and able to written informed consent (ICF) .\n2. Age ≥ 18 years and ≤ 75 years.\n3. Histologically confirmed Diffuse Large B-Cell Lymphoma of the germinal center B-cell(DLBCL) subtype by Hans.\n4. Patients no prior chemotherapy or radiotherapy for DLBCL, with the exception of no more than 5 days of treatment with glucocorticoids for symptom control.\n5. International Prognostic Index score of 3-5.\n6. Computed Tomography(CT)\u002FPositron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than \\> 1.5cm or 1 extranodal lesion with LDi \\>1 cm.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n8. Adequate bone marrow function at Screening(Except for underlying diseases, such as secondary hypersplenism due to bone marrow invasion or splenic invasion identified by the investigator).\n\n   1. Absolute neutrophil count (ANC)≥1.5×109\u002FL;\n   2. Platelet count (PLT) ≥100×109\u002FL(no platelet transfusion within 14 days prior to C1D1), or PLT≥ 75×109\u002FL if due to lymphoma with bone marrow involvement.\n   3. Hemoglobin (HB)≥85g\u002FL(no red blood cell transfusion within 14 days prior to C1D1).\n9. Adequate hepatic and renal function:\n\n   1. Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤2.0 x upper limit of normal (ULN), or AST and ALT≤5.0 x ULN(if due to lymphoma involvement),\n   2. Serum total bilirubin ≤2×ULN, or Serum total bilirubin ≤5×ULN if due to Gilbert syndrome or lymphoma involvement.\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin (calculated using the formula of Cockroft-Gault).\n10. Participants of childearing potential must agree to use highly effective methods of contraception during the duration of the study and following the last dose of study treatment, female and male participants should continue contraception for 14 and 11 months, respectively.\n\n    1. Female participants of childbearing potential must have a negative serum pregnancy test at screening(Non-Childbearing potential: Age \\>50 years and naturally amenorrhoeic for \\>1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy).\n    2. Male participants must agree to avoid sperm donation during the duration of the study and 14 months following the last dose of study treatment.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be enrolled:\n\n1. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma.\n2. Known active central nervous system lymphoma or meningeal involvement at screening. Participants with a history of CNS disease treated into remission may be enrolled. The DLBCL of Testis involvement or more than two extranodal involvement.\n3. Previous treatment with selinexor or other XPO1 inhibitors.\n4. Contraindication to any drug contained in these regimen.\n5. Major surgery \\\u003C14 days of C1D1, Except for disease diagnosis.\n6. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the participant's safety, or able to comply with the study procedures.\n7. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).\n8. Subjects with known active Hepatitis B (HB) infection, active Hepatitis C (HCV) infection or Human Immunodeficiency Virus (HIV) positivity. Participants with active hepatitis B Virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for \\>8 weeks and viral load is \\\u003C100 international units per milliliter (IU\u002FmL); participants with untreated hepatitis C Virus (HCV) are eligible if viral load is negative per institutional standard; participants with human immunodeficiency virus (HIV) are eligible if cluster of differentiation 4 (CD4+) T-cell counts ≥350 cells per microliter (cells\u002FμL), viral load is negative and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year.\n9. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral).\n10. Breastfeeding women or pregnant women.\n11. In the opinion of the Investigator, participants who are below their ideal body weight and would be unduly impacted by changes in their weight.\n12. Life expectancy of less than 6 months.","75 Years",{"count":108,"type":20},50,[23],"This is a phase II, multicenter, single-arm and open-label study to explore Selinexor in combination with standard of care R-CHOP in New Diagnosed high-risk GCB-subtype DLBCL (IPI 3-5). Approximately 35 patients plan to be enrolled in about 6-8 study sites of the study. And the objective is to Evaluate the safety and efficacy of XR-CHOP in High-Risk (IPI 3-5) GCB-subtype DLBCL.The enrollment period for this study is expected to be approximately 18 months. The study will end when all patients have completed 6 cycles treatment\u002Ffollow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.",[112],"DLBCL Germinal Center B-Cell Type",[114,115,116,117,118],"Selinexor","Xpovio","Newly Diagnosed","DLBCL","IPI 3-5","2024-06-14",{"date":121,"type":33},"2024-06-17",{"date":123,"type":33},"2022-07-26",{"date":125,"type":20},"2025-12-31",{"name":39,"class":40},6,""]