Clinical Study of CEP+Dasatinib + Azacytidine in First-line Treatment of. Angioimmunoblastoma Foresight

未提供1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2023年10月21日最近更新: 2025年7月1日

干预措施

试验速览

阶段: 4 期
状态: 进行中（未招募）
入组人数: 34
试验地点: 1
主要终点: progression free survial

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To observe the efficacy and safety of the CEP + Dasatinib + Azacitidine as the first-line treatment regimen for patients with Angioimmunoblastic T-cell Lymphoma.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•1.Age 18-75 years, ECOG 0-
•2.Life expectancy >6 months. 3.Pathologically confirmed AITL. 4.Acceptable hematological parameters (neutrophils ≥1.0×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥80 g/L [except for bone marrow infiltration]).
•5.At least one measurable lesion (lymph node: long diameter ≥1.5 cm, short diameter ≥1.0 cm; extranodal: long diameter ≥1.0 cm).
•6.Liver function: TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, ALP ≤3×ULN (non-bone infiltration).
•7.Renal function: serum creatinine ≤1.5×ULN. 8.No severe comorbidities; normal cardiac function. 9.Willingness to use contraception; negative pregnancy test for 育龄期女性 (within 7 days prior to first dose).
•10.Informed consent and compliance with follow-up. 11.No concurrent anti-tumor therapies (e.g., traditional Chinese medicine, immunotherapy, biological agents).

排除标准

•1.Patients with definite neurological or psychiatric diseases, including dementia or epilepsy, with a history of psychotropic drug abuse and inability to quit, or other substantive lesions that may increase central neurotoxicity; 2.Those who are participating in other clinical trials or have participated in other clinical research within the previous 4 weeks (except those who have not received treatment); 3.Systemic autoimmune diseases or immunodeficiency; 4.Refusal to provide blood samples; 5.Allergic to any drug in the plan; 6.Pregnant and lactating women; 7.Subjects with significant diseases that may interfere with the trial and with uncontrolled active infections; 8.Primary or relapsed central nervous system tumors; 9.Contraindications for chemotherapy; 10.Researchers believe that they are not suitable for inclusion; 11.Any active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding superficial skin or mucosal infections) or any major systemic infectious diseases (septicemia, etc.) that require antibiotic treatment or hospitalization within the previous 4 weeks before inclusion; 12.Those who have received anti - tumor treatment (such as radiotherapy, chemotherapy, immunotherapy, biotherapy, immunotherapy); 13.Other severe conditions that may prevent the subject from participating in this trial, such as uncontrolled diabetes: Severe cardiac insufficiency (NYHA grade III or above); Acute coronary syndrome occurred within the previous 6 months; Coronary artery bypass grafting or stent implantation, mitral valve surgery, and other heart and major vascular - related surgeries within the previous 6 months; Severe arrhythmias including bradycardia, tachycardia, fast atrial fibrillation, atrial flutter, uncontrolled severe hypertension (systolic pressure ≥ 180 mmHg, diastolic pressure ≥ 110 mmHg), peptic ulcer disease (subjects judged to have a perforated peptic ulcer); Active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, polymyositis, scleroderma, autoimmune hemolytic anemia, etc.); Severe respiratory system diseases (such as bronchial asthma and pulmonary emphysema, etc.).
•14.Thrombocytopenic purpura patients; 15.Patients with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and whose peripheral blood hepatitis B virus (HBV) DNA titer is not within the normal reference range; patients with positive hepatitis C virus (HCV) antibody and whose peripheral blood hepatitis C virus (HCV) RNA is positive; patients with positive human immunodeficiency virus (HIV) antibody; patients with positive cytomegalovirus (CMV) DNA test; patients with positive syphilis test

研究组 & 干预措施

group1

Experimental

CEP + Dasatinib + Azacitidine

干预措施: CEP + Dasatinib + Azacitidine (Biological)

结局指标

主要结局

progression free survial

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方

未提供

研究点 (1)

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