[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522713":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":20,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Zhejiang Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A+RGEMOX","EXPERIMENTAL","A-RGEMOX regimen (21 days per cycle, A total of 6 cycles) :\n\nAllotinib: 12mg d1\\~14 po qd, Rituximab: 375mg\u002Fm2 d1, gemcitabine: 1000mg\u002Fm2 d1 and d8, oxaliplatin: 130mg\u002Fm2 d1",[13],"Drug: Anlotinib hydrochloride, Rituximab, gemcitabine, oxaliplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Anlotinib hydrochloride, Rituximab, gemcitabine, oxaliplatin","Anlotinib: 12mg d1\\~14 po qd, Rituximab: 375mg\u002Fm2 d1, gemcitabine: 1000mg\u002Fm2 d1 and d8, oxaliplatin: 130mg\u002Fm2 d1;\n\nFor subjects ≥75 years of age, appropriate reduction of chemotherapy drugs (not less than 75% of the standard dose, or withdrawal of day 8 gemcitabine) may be decided by the investigator.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Haiyan Yang","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Xi Chen","CONTACT","+8617816890591","zjuchenxi@126.com",{"name":23,"role":28,"phone":32,"phoneExt":20,"email":33},"0086-571-88122192","yanghy@zjcc.org.cn",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.16142,30.29365,{"lat":46,"lon":45},[49,51,53],{"name":50,"role":28,"phone":32,"phoneExt":20,"email":33},"Haiyan Yang, PhD",{"name":52,"role":28,"phone":32,"phoneExt":20,"email":30},"Xi Chen, MD",{"name":52,"role":54,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":24,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Yang haiyan","Chief physician","100522713","phase-2-a-rgemox-in-the-treatment-of-early-relapsedrefractory-dlbcl-100522713",false,"NCT06086197","A-RGEMOX in the Treatment of Early Relapsed\u002FRefractory DLBCL","Prospective, Single-center, Phase II Clinical Study of Anlotinib in Combination With Rituximab，Gemcitabine and Oxaliplatin (A-RGEMOX) in the Treatment of Early Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Participate in the clinical study voluntarily: fully understand and be informed of the study and sign the informed consent in person; Willing to follow and be able to complete all test procedures.\n* Age≥18 years old, ECOG score ≥2 points, both male and female.\n* Histopathologically confirmed as diffuse large B-cell lymphoma, not otherwise specified; high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; high-grade B-cell lymphoma, not otherwise specified; EBV positive diffuse large B-cell lymphoma\n* Must meet one of the following conditions:\n\n  1. Early relapse: response (≥PR) to first-line systemic therapy (including rituximab and anthracyclines) and disease progression within 12 months after the end of treatment;\n  2. Refractory: first-line treatment includes rituximab and anthracyclines, and no response has been achieved with the most recent systemic treatment (≥PR).\n* At least one evaluable or measurable lesion that meets Lugano2014 criteria (evaluable lesion: PET\u002FCT examination showing increased uptake in lymph nodes or extranodal areas (higher than liver) and PET\u002FCT and\u002For CT consistent with lymphoma; Measurable lesions: nodular lesions \\>15mm in length or extragendal lesions \\>10mm in length with increased FDG uptake).\n* Adequate organ and bone marrow function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency:\n\n  1. Neutrophil absolute count (ANC) ≥1.5×109\u002FL (1500\u002Fmm3), platelet ≥75×109\u002FL, hemoglobin ≥100g\u002FL (if bone marrow is involved, platelet ≥50×109\u002FL, ANC ≥1.0×109\u002FL, hemoglobin ≥80g\u002FL).\n  2. Liver function: serum bilirubin ≤2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5 times the upper limit of normal value (AST or ALT≤5 times the upper limit of normal value is allowed if liver is involved).\n  3. Renal function: creatinine clearance ≥60 mL\u002Fmin (estimated according to the Cockcroft-Gault formula).\n  4. Coagulation function: INR≤1.5 times the upper limit of normal value; PT and APTT≤1.5 times the upper limit of normal value.\n* Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.\n* Negative serum pregnancy test and effective contraceptive use from signing informed consent until 6 months after the last chemotherapy.\n* Life expectancy \\> 3 months.\n\nExclusion Criteria:\n\n* Pathological subtypes: primary central nervous system diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma.\n* Hemophagocytic syndrome at the time of diagnosis.\n* Central nervous system involvement secondary to lymphoma.\n* Participating in other clinical studies, or the first study drug is administered less than 4 weeks after the end of treatment in the previous clinical study.\n* Medical history of other active malignancy within 2 years prior to enrollment, except for the following conditions:(1) adequately treated in situ of the cervix carcinoma; (2) local basal cell carcinoma or squamous cell carcinoma of skin; (3) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).\n* History of Human Immunodeficiency Virus (HIV) infection and\u002For acquired Immunodeficiency syndrome. Patients with positive hepatitis B surface antigen or hepatitis C virus antibody must be tested hepatitis B virus DNA (no more than 1000 iu\u002Fml) and HCV RNA detection (below the detection limit). Patients with hepatitis B virus carriers, or stabilized hepatitis B with anti-virus treatment and cured hepatitis C can be included.\n* Major surgery was performed within 28 days prior to study initiation.\n* Any active infection, including bacterial, fungal or viral infections, that requires systemic antiinfection therapy within 14 days prior to treatment.\n* Accompanied with severe or uncontrolled disease, including symptomatic of congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer or A history of severe hemorrhagic diseases, such as hemophilia A, hemophilia B, von willebrand disease or blood transfusion or other medical intervention history of spontaneous bleeding.\n* History of stroke or intracranial hemorrhage within 6 months prior to first administration of the study drug.\n* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months.\n* Patients who must take antiplatelet drugs and anticoagulants at the same time due to underlying diseases, and there is no alternative treatment plan.\n* Continuous treatment with strong CYP1A2 and CYP3A inhibitors or inducers is required. Patients were excluded if they had taken a strong CYP1A2 and CYP3A inhibitors or inducer within 7 days prior to the first administration of the study drug (or had taken these drugs for less than 5 half-lives).\n* Hypersensitivity to the experimental drug is known.\n* Patients deemed unsuitable for the study by researchers.","ALL","18 Years",{"count":68,"type":69},41,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","As the most common subtype of lymphoma, diffuse large B-cell lymphoma (DLBCL) is an aggressive but potentially curable malignancy. However, patients with early relapse (relapse within 12 months since diagnosis or the end of first-line treatment, ER) or primary refractory had an even worse prognosis. Thus, the investigators plan to evaluate the efficacy and safety of anlotinib combined with rituximab, gemcitabine, oxaliplatin (A-RGEMOX) in the treatment of early relapsed\u002Frefractory diffuse large B-cell lymphoma.",[75,76],"Diffuse Large B-cell Lymphoma Recurrent","Diffuse Large B Cell Lymphoma Refractory",[78,79,80,81],"angiogenesis","anlotinib","early relapse","treatment","2024-06-23",{"date":84,"type":85},"2024-06-25","ACTUAL",{"date":87,"type":85},"2023-10-01",{"date":89,"type":69},"2026-10",{"name":5,"class":6},1]