[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568642":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":48,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Zhengzhou University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Elderly patients with newly diagnosed DLBCL","EXPERIMENTAL","Obutinib or Decitabine with Rituximab, Compound Cyclophosphamide Tablets and Prednisone",[13],"Drug: Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Obutinib or Decitabine, Rituximab, Compound Cyclophosphamide Tablets and Prednisone","For non GCB type: Rituximab, 375mg\u002Fm2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Obutinib, 150mg, QD, P.O.; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Obutinib maintain treatment for 6 months. Obutinib, 150mg, QD, P.O. After 6 cycles of initial treatment, the efficacy was evaluated.\n\nFor GCB type: Rituximab, 375mg\u002Fm2, QD, D1,8,15(the first cycle), d1(Starting from the second cycle), ivgtt; Compound Cyclophosphamide Tablets, 50mg:50mg BID, P.O.; Decitabine, 10mg, QD，D1-5, ivgtt; Prednisone, 60mg, QD D1-7, P.O. Every 21 days is a cycle, and the efficacy is evaluated every 2 cycles. Decitabine maintenance treatment for 4 cycles, 21 days per cycle. Decitabine, 10mg, QD，D1-5, ivgtt. Evaluate the efficacy after 6 cycles of treatment.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Mingzhi Zhang, Doctor","CONTACT","13838565629","Mingzhi_zhang@126.com",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":20},"Lei Zhang, Doctor","13525533696",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Oncology Department of The First Affilliated Hospital of Zhengzhou University","RECRUITING","Zhengzhou","Henan","450052","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.64861,34.75778,{"lat":43,"lon":42},[46],{"name":23,"role":24,"phone":47,"phoneExt":20,"email":26},"+8613838565629",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Mingzhi Zhang","the director of oncology department of the first affiliated hospital","100568642","phase-1-a-prospective-clinical-study-of-the-combination-therapy-of-obutinib-or-decitabine-with-rituximab-cyclophosphamide-and-prednisone-for-the-primary-treatment-of-elderly-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-100568642",false,"NCT06683885","A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Individuals aged 65 years or older who are intolerant to chemotherapy, regardless of gender;\n2. ECOG 0-1； IPI score ≤ 3 points;\n3. Expected survival period of more than 3 months;\n4. DLBCL diagnosed by tissue biopsy pathology;\n5. No contraindications for chemotherapy (blood and physiological examination results within 7 days), absolute neutrophil count ≥ 1.0 × 10 \\^ 9\u002FL, PLT ≥ 75 × 10 \\^ 9\u002FL, hemoglobin ≥ 80g\u002FL (excluding patients with lymphoma bone marrow infiltration);\n6. According to the RECIST criteria, there must be at least one measurable lesion. For intranodal lesions, it is defined as: long diameter ≥ 1.5cm and short diameter ≥ 1.0cm; For extranodal lesions, the length and diameter should be ≥ 1.0cm;\n7. Liver function: TBIL ≤ 1.5 × ULN; ALT or AST ≤ 2.5 × ULN; Non bone invasive patients with alkaline phosphatase ≤ 3 × ULN;\n8. Renal function: serum creatinine ≤ 1.5 × ULN;\n9. No other serious illnesses that conflict with this plan;\n10. Excluding other major illnesses, the heart function is normal;\n11. There are no other related treatments including traditional Chinese medicine (anti-tumor effects), immunotherapy, or biologic therapy (except for treatment of bone metastasis and other symptoms);\n12. The subjects voluntarily participate in the clinical trial, sign an informed consent form, and cooperate with follow-up;\n13. During this treatment period, if other anti-tumor drugs are not used simultaneously, bisphosphonates can be used for bone metastasis treatment and other symptomatic treatments;\n\nExclusion Criteria:\n\n1. Clear patients with neurological or psychiatric disorders, including dementia or seizures, a history of abuse of psychotropic drugs that cannot be quit, or other substantial lesions that may increase central neurotoxicity;\n2. Individuals who are currently participating in other clinical trials or have participated in other clinical studies within the first 4 weeks of enrollment (excluding those who have not received treatment);\n3. Systemic autoimmune diseases or immunodeficiency;\n4. Refusing to collect blood samples;\n5. Allergic to any medication in the plan;\n6. Pregnant and lactating women;\n7. Major diseases that can cause experimental interference and uncontrolled active infections;\n8. Primary or secondary central tumors;\n9. Chemotherapy contraindications;\n10. Within 28 days of using Rituximab\u002FObutinib\u002FCompound Cyclophosphamide Tablets\u002FAzacitidine;\n11. Researchers believe that it is not suitable for inclusion;\n12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed skin fungal infections) or any major systemic infection requiring intravenous antibiotic treatment or hospitalization within the 4 weeks prior to enrollment (excluding tumor fever);\n13. Apply other anti-tumor treatments (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);\n14. Other serious diseases that may restrict the subjects from participating in the test, such as uncontrollable diabetes; Severe heart failure (NYHA grade II or above); Acute coronary syndrome has occurred within the past 6 months; Coronary revascularization such as stent implantation, coronary artery bypass surgery, and other heart and large vessel related surgeries within the past 6 months; Severe arrhythmias include frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation\u002Fflutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure\\>150mmHg, diastolic blood pressure\\>100mmHg. Gastric ulcer (determined by researchers to have a risk of perforation); Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc;\n15. Individuals with bloodthirsty cell syndrome;\n16. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive hepatitis C virus (HCV) RNA in peripheral blood; Individuals who are HIV antibody positive; Individuals who test positive for Cytomegalovirus (CMV) DNA; Individuals who test positive for syphilis.","ALL","65 Years",{"count":61,"type":62},80,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","A Prospective Clinical Study of the Combination Therapy of Obutinib or Decitabine with Rituximab, Cyclophosphamide, and Prednisone for the Primary Treatment of Elderly Patients with newly Diagnosed Diffuse Large B-cell Lymphoma",[69],"Newly Diagnosed Diffuse Large B-cell Lymphoma",[71,72,73,74,75,76,77],"DLBCL","clinical trial","chemotherapy","PFS","ORR","Obutinib","Decitabine","2024-11-08",{"date":80,"type":81},"2024-11-12","ACTUAL",{"date":83,"type":62},"2024-11-20",{"date":85,"type":62},"2026-05-01",{"name":50,"class":6},1]