[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fei Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100569942","phase-2-orelabrutinib-combined-with-rituximab-versus-r-cvp-in-the-untreated-mzl-a-randomized-open-phase-ii-trial-100569942",false,"NCT06700798","Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL： A Randomized, Open Phase II Trial","A Randomized, Open-Label Phase II Clinical Study of Orelabrutinib Combined With Rituximab Versus R-CVP in the Treatment of Newly Diagnosed Marginal Zone Lymphoma (MZL).","Inclusion Criteria:\n\n1.Age ≥18 years； 2.ECOG performance status level 0\\~2； 3.Life expectancy of at least 12 weeks; 4.Confirmed CD20-positive marginal zone lymphoma according to the WHO 2008 lymphoma classification criteria, including splenic MZL, nodal MZL, and extranodal MZL subtypes; 5.Measurable lesions detected by enhanced computed tomography (CT) or magnetic resonance imaging (MRI); 6.Indication for treatment according to NCCN guidelines and no prior systemic treatment for MZL; 7.Normal function of major organs; 8.Women of childbearing age must have taken reliable contraceptive measures or undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and must be willing to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication. For men, they must agree to use appropriate contraceptive methods during the trial period and for 8 weeks after the last administration of the trial medication or have undergone surgical sterilization; 9.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with follow-up.\n\n\\-\n\nExclusion Criteria:\n\n1. Patients with central nervous system involvement;\n2. History or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer;\n3. Patients with the following cardiovascular diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval for males ≥450 ms, for females ≥470 ms); Class III to IV heart failure according to NYHA standards, or echocardiography indicating left ventricular ejection fraction (LVEF) \\\u003C50%;\n4. Coagulation abnormalities (INR \\>1.5 or prothrombin time (PT) \\>ULN+4 seconds or APTT \\>1.5 ULN), with a tendency to bleed or undergoing thrombolytic or anticoagulant therapy;\n5. Arterial\u002Fvenous thrombotic events within 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n6. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation disorders, thrombocytopenia, hypersplenism, etc.);\n7. Major surgical procedures or severe traumatic injuries, fractures, or ulcers within 4 weeks prior to enrollment;\n8. Factors that significantly affect the absorption of oral medications, such as inability to swallow, chronic diarrhea, and intestinal obstruction;\n9. Active infections requiring antimicrobial treatment (e.g., requiring antibacterial, antiviral drugs, excluding chronic hepatitis B antiviral treatment, antifungal treatment);\n10. Active hepatitis B (HBV DNA ≥2000 IU\u002FmL or 104 copies\u002FmL) or hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of detection of the analytical method);\n11. History of substance abuse and inability to quit or mental disorders;\n12. Participation in other anticancer drug clinical trials within 4 weeks prior to enrollment;\n13. Received treatment with potent CYP3A4 inhibitors within 7 days prior to enrollment, or received treatment with potent CYP3A4 inducers within 12 days prior to study participation;\n14. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to use effective contraceptive measures;\n15. Other situations judged by the investigator that may affect the conduct of the clinical study and the determination of study results.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL",[26],"Marginal Zone Lymphoma(MZL)",[28],"Orelabrutinib combined with Rituximab versus R-CVP","RECRUITING","2025-06-14",{"date":32,"type":33},"2025-06-17","ACTUAL",{"date":35,"type":33},"2024-12-01",{"date":37,"type":20},"2027-12-04",{"name":39,"class":40},"Fei Li","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100552731","phase-2-a-practical-clinical-study-comparing-the-fixed-cycle-regimen-containing-orelabrutinib-with-btki-monotherapy-100552731","NCT06476899","A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy","A Practical Clinical Study Comparing the Fixed-cycle Regimen Containing Orelabrutinib With BTKi Monotherapy in Previously Untreated CLL\u002FSLL","Inclusion Criteria:\n\n* Age between 18 and 70 years, with no gender restrictions;\n* Patients with CLL\u002FSLL who meet the iwCLL2018 diagnostic criteria;\n* Indications for treatment\n* ECOG performance score of 0-2;\n* Patients are untreated or have not received standardized treatment\n* Before the trial screening, the subject or their legal representative voluntarily signs a written informed consent form, indicating that they understand the purpose of the study and the necessary research steps, and are able to comply with the protocol and follow-up.\n\nExclusion Criteria:\n\n* Has been diagnosed or treated for malignancies other than CLL (including active central nervous system lymphoma) within the past year;\n* there is clinical evidence of Richter transformation;\n* Participant cannot receive or plan to receive another treatment during study participation\n* Other conditions that the investigator considers inappropriate for participation","70 Years",{"count":51,"type":20},60,[23],"Prospective, interventional, and practical clinical studies",[55],"CLL\u002FSLL","NOT_YET_RECRUITING","2024-06-21",{"date":59,"type":33},"2024-06-27",{"date":61,"type":20},"2024-07-24",{"date":63,"type":20},"2026-12-26",{"name":39,"class":40},""]