[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566206":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":38,"collaborators":25,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":25,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"zanubrutinib combined with BEAM","EXPERIMENTAL","zanubrutinib combined with camustine, etoposide, cytarabine, and mafaran (BEAM)",[13],"Drug: zanubrutinib combined with BEAM",{"label":15,"type":16,"description":17,"interventionNames":18},"BEAM","ACTIVE_COMPARATOR","camustine, etoposide, cytarabine, and mafaran (BEAM)",[19],"Drug: BEAM",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","zanubrutinib：160mg oral bid D-8-D-2 camustine: 300mg\u002Fm2 vgtt qd D-8 etoposide: 100mg\u002Fm2\u002Fd vgtt q12h D-7-D-4 cytarabine: 200mg\u002Fm2\u002Fd vgtt q12h D-7-D-4 melphalan: 140mg\u002Fm2 vgtt qd D3-D-2",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"camustine: 300mg\u002Fm2 vgtt qd D-8 etoposide: 100mg\u002Fm2\u002Fd vgtt q12h D-7-D-4 cytarabine: 200mg\u002Fm2\u002Fd vgtt q12h D-7-D-4 melphalan: 140mg\u002Fm2 vgtt qd D3-D-2",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Wei-Li Zhao, professor","CONTACT","+862164370045","zwl_trial@163.com",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Meng-Meng Ji, doctor","jimengmeng025@163.com",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Zhao Weili","professor","100566206","phase-2-zanubrutinib-combined-with-beam-for-asct-in-relapsed-and-refractory-dlbcl-100566206",false,"NCT06652165","Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL","A Single-center, Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL","Inclusion Criteria:\n\n1. According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;\n2. 18≤ age ≤65 years old, male or female;\n3. ECOG score 0-2;\n4. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :\n\n   1. White blood cell count ≥3.0×109\u002FL, absolute neutrophil count ≥1.5×109\u002FL, Hemoglobin ≥90g\u002FL, platelet ≥75×109\u002FL;\n   2. Total bilirubin ≤1.5× upper normal value (ULN);\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN\n   4. Creatinine clearance was 44-133 mmol\u002FL;\n5. No cardiac dysfunction;\n6. Life expectancy over 3 months;\n7. The subject or his\u002Fher legal representative must provide written informed consent prior to conducting a special study examination or procedure.\n\nExclusion Criteria:\n\n1. Previously received autologous hematopoietic stem cell transplantation;\n2. Suffering from serious complications or severe infection;\n3. Previous treatment with selinexor;\n4. Central nervous system lymphoma was excluded;\n5. A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;\n6. Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;\n7. HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA\u002FRNA testing must be negative;\n8. Left ventricular ejection fraction ≦ 50%;\n9. Laboratory test value during screening;\n\n   ① Neutrophils \\\u003C1.5×109\u002FL; Platelet \\\u003C75×109\u002FL;\n\n   ② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;\n\n   ③ The creatinine level is higher than 1.5 times the upper limit of normal value;\n10. Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;\n11. Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;\n12. Pregnant or lactating women;\n13. The researcher judged that the patients were not suitable for this study.","ALL","18 Years","65 Years",{"count":53,"type":54},66,"ESTIMATED","INTERVENTIONAL",[57],"PHASE2","This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.",[60],"DLBCL","NOT_YET_RECRUITING","2024-10-21",{"date":64,"type":65},"2024-10-22","ACTUAL",{"date":67,"type":54},"2024-11-01",{"date":69,"type":54},"2028-11-01",{"name":5,"class":6}]