[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648368":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":71,"collaborators":22,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":22,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":22,"enrollmentInfo":82,"targetDuration":22,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"orelabrutinib (O) combined with obinutuzumab (G) and short-course venetoclax (V)","EXPERIMENTAL","Induction Phase (6 cycles, 28 days per cycle)： Orelabrutinib + Obinutuzumab\n\n\\+ Venetoclax.\n\nPatients achieving partial response (PR) or complete response (CR) after 3 cycles will receive an additional 3 cycles of induction therapy.Patients with stable disease (SD) or progressive disease (PD) after 3 cycles will be withdrawn from the study.Patients achieving PR or CR at the end of induction will proceed to the maintenance phase (Cycles 7-24).Patients with SD or PD at the end of induction will be withdrawn from the study.\n\nMaintenance Phase (18 cycles, 28 days per cycle)：\n\nOrelabrutinib + Obinutuzumab\n\n\\+ Venetoclax",[13,14,15],"Drug: Orelabrutinib","Drug: Obinutuzumab","Drug: Venetoclax",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Orelabrutinib","Orelabrutinib: 150 mg, d1-d28, C1-C6 (Induction Phase ) ; 150 mg, d1-d28, C7-C24 (Maintenance Phase)",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Obinutuzumab","Obinutuzumab: 1000 mg\u002Fm², on d1, d8, and d15 in C1; and on d1 in C2-C6 (Induction Phase ) ; 1000 mg\u002Fm², d1, once every 2 cycles, C7-C24 (Maintenance Phase)",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Venetoclax","Venetoclax: dose ramp-up in C2 (20 mg → 400 mg); 400 mg on d1-d14 in C3-C6(Induction Phase ) ; 400 mg, d1-d14, C7-C24(Maintenance Phase)",[9],[32],{"name":33,"affiliation":5,"role":34},"Yi Xia","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":22,"email":39},"CONTACT","+8613770698391","cynthia0311@163.com",[41,59],{"facility":42,"status":43,"city":44,"state":45,"zip":22,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Changzhou Second People's Hospital","RECRUITING","Changzhou","Jiangsu","China","CN",{"type":49,"coordinates":50},"Point",[51,52],119.95401,31.77359,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":22,"email":58},"Xuzhang Lu","86051988104931","luxuzhang2008@163.com",{"facility":60,"status":43,"city":61,"state":45,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Jiangsu province Hospital","Nanjing","210029",{"type":49,"coordinates":64},[65,66],118.77778,32.06167,{"lat":66,"lon":65},[69],{"name":33,"role":37,"phone":70,"phoneExt":22,"email":39},"86 25 86307573",{"type":72,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100648368","phase-2-orelabrutinib-combined-with-obinutuzumab-and-short-course-venetoclax-in-patients-with-treatment-nave-mantle-cell-lymphoma-mcl-100648368",false,"NCT07719556","Orelabrutinib Combined With Obinutuzumab and Short-Course Venetoclax in Patients With Treatment-Naïve Mantle Cell Lymphoma (MCL)","A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study of Orelabrutinib in Combination With Obinutuzumab and Short-course Venetoclax in Patients With Treatment-naïve Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form;\n2. Age ≥ 18 years, male or female;\n3. Life expectancy ≥ 3 months;\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Patients with ECOG 3 may be enrolled only if the decline in performance status is attributed to the underlying disease and the investigator determines that they may benefit from the treatment;\n5. Pathologically confirmed diagnosis of mantle cell lymphoma (MCL) and treatment-naïve;\n6. Presence of measurable and\u002For evaluable lymphoma lesions;\n7. Adequate bone marrow reserve, defined as: absolute neutrophil count \\> 1.0×10⁹\u002FL or platelet count \\> 75×10⁹\u002FL, unless cytopenias are considered to be related to bone marrow involvement by lymphoma and deemed recoverable by the investigator;\n8. Hepatic function: AST (SGOT) and ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN) (in the absence of liver involvement) or ≤ 5 × ULN (in the presence of liver involvement); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;\n9. Creatinine clearance ≥ 30 mL\u002Fmin, calculated using the Cockcroft-Gault formula;\n10. Able to comply with the study visit schedule and other protocol requirements;\n11. All patients of childbearing potential must agree to use effective contraceptive measures during the study and for 24 months after study treatment discontinuation. Female patients of childbearing potential must have a negative urine pregnancy test prior to the first dose of study treatment.\n\nExclusion Criteria:\n\n1. Received prior treatment for lymphoma within 2 weeks before study enrollment;\n2. Any serious medical condition, including but not limited to:\n\n   * Uncontrolled hypertension (defined as blood pressure that remains uncontrolled after at least 4 weeks of treatment with a reasonable and tolerable regimen of 3 or more antihypertensive agents \\[including diuretics\\] at adequate doses, or requiring 4 or more antihypertensive agents to achieve adequate control);\n\n     * Uncontrolled congestive heart failure within 6 months prior to screening (New York Heart Association \\[NYHA\\] Class III \\[moderate\\] or Class IV \\[severe\\] cardiac disease);\n\n       * Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n\n         * Symptomatic coronary artery disease (e.g., chest tightness, chest pain, palpitations, fatigue) or coronary artery disease requiring medical therapy; ⑤Severe bradycardia (heart rate \\\u003C 40 beats per minute \\[bpm\\]) with hypotension, dizziness, or syncope; patients with a history of arrhythmia should undergo cardiac evaluation;\n\n           * Known active bacterial, viral, fungal, or other infection (excluding fungal infection of the nail bed), or major infection within 2 weeks prior to the first dose of study drug;\n\n             * Moderate to severe hepatic impairment (Child-Pugh Class B or C); ⑧Active bleeding within 2 months prior to screening, or clear evidence of bleeding diathesis as judged by the investigator; ⑨Current pulmonary disease that impairs lung function, such as pulmonary fibrosis or drug-related pneumonitis, which is deemed intolerable by the investigator; ⑩Any psychiatric or cognitive disorder that may limit the patient's ability to understand, execute, or comply with the informed consent and study requirements;\n3. Known active hepatitis C virus (HCV) infection; or other acquired or congenital immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) infection;\n4. All patients with central nervous system (CNS) involvement by lymphoma;\n5. Diagnosis of or receiving treatment for another malignancy other than lymphoma, except for the following:\n\n   ①Malignancy that has been treated with curative intent and with no known active disease for ≥ 5 years prior to enrollment;\n\n   ②Adequately treated basal cell carcinoma of the skin (excluding melanoma) with no evidence of disease;\n\n   ③Adequately treated carcinoma in situ of the cervix with no evidence of disease;\n6. Known hypersensitivity to any study drug;\n7. Pregnant or breastfeeding women;\n8. History of stroke or intracranial hemorrhage within 6 months prior to enrollment;\n9. Requirement for anticoagulation therapy with warfarin or equivalent vitamin K antagonists;\n10. Requirement for long-term treatment with strong cytochrome P450 3A (CYP3A) inhibitors;\n11. Receipt of live attenuated vaccine within 4 weeks prior to enrollment.","ALL","18 Years",{"count":83,"type":84},39,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","This study aims to evaluate the safety and efficacy of orelabrutinib (O) in combination with obinutuzumab (G) and short-course venetoclax (V) in patients with treatment-naïve MCL.",[90],"Mantle Cell Lymphoma (MCL)",[92,93,94,95],"orelabrutinib","MCL","obinutuzumab","venetoclax","2026-07-21",{"date":98,"type":99},"2026-07-22","ACTUAL",{"date":101,"type":84},"2026-07-15",{"date":103,"type":84},"2029-07-01",{"name":5,"class":6},2]