[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509810":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":58,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":11,"enrollmentInfo":70,"targetDuration":11,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OBG","EXPERIMENTAL",null,[13],"Drug: Orelabrutinib and BG",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Orelabrutinib and BG","Drug: Orelabrutinib Orelabrutinib 200mg, po, qd，C2-C7. Twenty-eight days for a cycle.\n\nDrug: BG Bendamustin 70mg\u002Fm2, IV, d2\\&d3 inC1, and then d1\\&d2 inC2-6.Twenty-eight days for a cycle.\n\nObintuzumab 100mg IV, d1, 900mg d2, 1000mg d8\\&d15 in C1, and then 1000mg\u002Fm2 IV, d1 in C2-6. Twenty-eight days for a cycle.",[9],[9],[22],{"name":23,"affiliation":5,"role":24},"Ru Feng, Master","STUDY_CHAIR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","+8602061641615","ruth1626@hotmail.com",{"name":31,"role":27,"phone":28,"phoneExt":11,"email":32},"Xutao Guo, Dr.","gxt827@126.com",[34,49],{"facility":35,"status":11,"city":36,"state":37,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"The Central Hospital Of Wuan","Wuhan","Hubei","China","CN",{"type":41,"coordinates":42},"Point",[43,44],114.26667,30.58333,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":11,"phoneExt":11,"email":11},"Hongxiang Wang",{"facility":50,"status":11,"city":51,"state":52,"zip":11,"country":38,"countryCode":39,"cosmosGeoPoint":53,"geoPoint":57,"contacts":11},"Hunan Cancer Hospital","Changsha","Hunan",{"type":41,"coordinates":54},[55,56],112.97087,28.19874,{"lat":56,"lon":55},{"type":59,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100509810","phase-2-clinical-study-of-orelabrutinib-combined-with-bg-regimen-first-line-treatment-of-cllsll-100509810",false,"NCT05918276","Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL\u002FSLL","Exploratory Clinical Study of Orelabrutinib in Combination With BG Regimen in Patients With Naive and Unfit CLL\u002FSLL Without 17p- or TP53 Mutations","CLL-OBG","Inclusion Criteria:\n\n* 65 years of age and older or between 18 and 65 years of age with severe illness (non-CLL\u002FSLL associated CIRS ≥ 6);\n* ECOG performance status (PS) level 0\\~2；\n* Expected survival is not less than 12 weeks;\n* Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma diagnosed by flow cytometry or histopathology according to IWCLL2008 criteria, and CD20 positive;\n* Meet at least 1 indication for treatment according to IWCLL2008 criteria or Chinese CLL\u002FSLL guidelines 2022\n* Enhanced computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI) to detect measurable lesions: at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension; for patients with chronic lymphocytic leukemia, only peripheral circulating lymphocyte count must be \\> 5000\u002FμL (or 5×10\\^9\u002FL);\n* Have not received systematic treatment for CLL\u002FSLL in the past;\n* The main organs are functioning normally, the following criteria are met:\n\n  1. Routine blood test standards should meet:\n\n     Absolute neutrophil (ANC) ≥1.0×109\u002FL, platelet (PLT) ≥30×109\u002FL; unless bone marrow and hematopoietic insufficiency is confirmed to be due to CLL\u002FSLL\n  2. Biochemical examination should meet the following standards:\n\n     1. TBIL\\\u003C2.0× ULN, CLL\u002FSLL liver involvement or confirmed Gilbert syndrome (normal direct bilirubin), total bilirubia ≤ 3 times ULN;\n     2. ALT and AST \\\u003C2.5×ULN (ALT and AST \\\u003C5×ULN for CLL\u002FSLL liver involvement);\n     3. Endogenous creatinine clearance ≥ 30 ml\u002Fmin (Cockcroft-Gault formula).\n* Women of childbearing age must have taken reliable contraceptive measures or have taken a pregnancy test (serum or urine) within 7 days prior to enrollment, have a negative result, and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, consent to appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug must be agreed;\n* Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with 17P- chromosome abnormalities or TP53 mutations;\n* Current or previous biopsy pathology confirms conversion to Richter's syndrome;\n* Have active and uncontrolled autoimmune cytopenias, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura;\n* Patients with central nervous system invasion;\n* Glucocorticoid therapy (at a dose equal to or greater than 20 mg\u002Fday of prednisone or equivalent) within 14 days prior to the first dose, excluding inhalation, topical medication, intra-articular medication, and prophylaxis before or after iodine contrast use; After discussion with the team leader, higher doses, longer steroid therapy may be allowed in the following cases:\n\n  1. treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL\u002FSLL disease;\n  2. Acute exacerbations due to short-term (within 14 days) use of inactive infections for diseases not associated with CLL\u002FSLL (e.g., arthritis, asthma), including steroid dose adjustment required for adrenal insufficiency;\n* Previous or concurrent uncured malignant tumors, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and superficial bladder cancer;\n* Suffering from the following cardiovascular diseases: grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval QTc \\>480ms); According to NYHA standards, grade III.\\~IV. cardiac insufficiency, or cardiac ultrasound showed left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Coagulation dysfunction (INR\\>1.5 or prothrombin time (PT) \\>ULN+4 seconds or APTT \\>1.5 ULN), bleeding tendency or receiving thrombolysis or anticoagulation therapy;\n* Arteriovenous thrombotic events that occurred within 12 months before enrollment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.;\n* Known hereditary or acquired bleeding and thrombosis (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.);\n* Have undergone major surgical procedures or developed severe traumatic injuries, fractures or ulcers within 4 weeks of enrollment;\n* Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction;\n* Active infection requiring antimicrobial therapy (such as antibacterial drugs and antiviral drugs, excluding chronic hepatitis B anti-hepatitis B treatment and antifungal treatment);\n* Active hepatitis B (HBV DNA≥2000 IU\u002FmL or 10000 copy number\u002FmL) or hepatitis C (positive for hepatitis C antibodies and HCV RNA above the lower limit of the assay);\n* Those who have a history of psychotropic substance abuse and cannot quit or have mental disorders;\n* Have participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;\n* Those who have received strong CYP3A4 inhibitor therapy within 7 days before enrollment, or received strong CYP3A4 inducer therapy within 12 days before participating in the study;\n* Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception; 19. Other circumstances that may affect the conduct of clinical research and the determination of research results as determined by the investigator.","ALL","18 Years",{"count":71,"type":72},24,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study aims to investigate the treatment of navie CLL\u002FSLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.",[78],"CLL\u002FSLL",[80,81,82],"Orelabrutinib","bendamustine","obintuzumab","NOT_YET_RECRUITING","2023-06-15",{"date":86,"type":87},"2023-06-26","ACTUAL",{"date":89,"type":72},"2023-07-15",{"date":91,"type":72},"2026-12-30",{"name":5,"class":6},2]