[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-diffuse-large-b-cell-lymphoma":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"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":18,"type":19},80,"ESTIMATED","INTERVENTIONAL",[22,23],"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",[26],"Newly Diagnosed Diffuse Large B-cell Lymphoma",[28,29,30,31,32,33,34],"DLBCL","clinical trial","chemotherapy","PFS","ORR","Obutinib","Decitabine","RECRUITING","2024-11-08",{"date":38,"type":39},"2024-11-12","ACTUAL",{"date":41,"type":19},"2024-11-20",{"date":43,"type":19},"2026-05-01",{"name":45,"class":46},"Mingzhi Zhang","OTHER","Newly Diagnosed Diffuse Large B-Cell Lymphoma"]