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A PROSPECTIVE PHASE II STUDY OF A HIGH DOSE, SHORT COURSE REGIMEN (R-CODOX-M/IVA

A PROSPECTIVE PHASE II STUDY OF A HIGH DOSE, SHORT COURSE REGIMEN (R-CODOX-M/IVA
高剂量、短疗程治疗方案 (R-CODOX-M/IVA) 的前瞻性 II 期研究
批准号:
8167104
负责人:
RONALD T. MITSUYASU
金额:
$0.15万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-11-30

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项目成果

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中文摘要
翻译
这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金, 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标: 主要目的:评价利妥昔单抗联合改良的CODOX-M/IVAC方案治疗艾滋病病毒相关性伯基特S(BL)或非典型伯基特S的疗效和安全性。 主要研究终点是一年的总生存期(OS),次要终点包括完全应答率(CR)、无故障生存率(FFS)、无事件生存率和毒性。 次要目标: 评估下游的细胞凋亡效应因子作为化疗耐药和预后的机制,并对它们与治疗效果的关系进行探索性分析。 评估多药耐药基因表达作为化疗耐药和预后的机制,并对其与治疗效果的关系进行探索性分析。 确认流式细胞术在鉴定隐匿性软脑膜疾病中的应用,并确定异常的流式细胞术是否可以预测中枢神经系统细胞学为阴性的恶性细胞。 确定EB病毒+伯基特S淋巴瘤在高效抗逆转录病毒治疗时代的生物学和预后意义,并对其与治疗效果的关系进行探索性分析。 评估BL的基因分型,确定它是否与HIV阴性病例中描述的相似。此外,确定病例的基因图谱是否一致,或者一些病例是否更像DLBCL。 确定确诊时在脑脊液中检测EBV是否可以预测软脑膜疾病。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: Primary Objectives: To determine the efficacy and safety of rituximab plus modified CODOX-M/IVAC regimen in patients with HIV-associated Burkitt s (BL) or atypical Burkitt s. The primary study endpoint is overall survival (OS) at one year, and secondary endpoints include complete response (CR) rate, failure-free survival (FFS), event-free survival, and toxicity. Secondary objectives: " Evaluate downstream effectors of apoptosis as mechanisms of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect. " Evaluate multi-drug resistance gene expression as a mechanism of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect. " Confirm the use of flow cytometry in the identification of occult leptomeningeal disease and determine whether abnormal flow cytometry is predictive of CNS cytology is negative for malignant cells. " Determine the biologic and prognostic significance of Epstein-Barr Virus (EBV) + Burkitt s Lymphoma (BL) in the highly active antiretroviral therapy (HAART) era and perform exploratory analysis of their relationship to treatment effect. " Evaluate genotyping in BL and determine whether it is similar to that described in HIV negative cases. Moreover, determine whether cases are uniform in their genetic profile or whether some cases are more like DLBCL. " Determine if EBV detection in CSF at diagnosis is predictive of leptomeningeal disease.
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