COGAALL1732：新诊断的高危B-ALL的伊诺图珠单抗奥佐霉素（IND#：133494，NSC#：772518）的第3阶段随机试验；高危B-ALL、混合表型急性白血病和播散性B-LL的风险适应性诱导后治疗

描述

这项III期试验研究了在高风险b细胞急性淋巴母细胞白血病(B-ALL)患者诱导后化疗中加入inotuzumab ozogamicin是否能改善预后。该试验还研究了混合表型急性白血病(MPAL)和b淋巴母细胞淋巴瘤(B-LLy)患者在使用ALL治疗而不使用inotuzumab ozogamicin时的预后。Inotuzumab ozogamicin是一种单克隆抗体，称为Inotuzumab，与一种称为calicheamicin的化疗有关。Inotuzumab以靶向的方式附着在癌细胞上，并传递calicheamicin杀死它们。化疗方案中使用的其他药物，如环磷酰胺、阿糖胞苷、地塞米松、阿霉素、柔霉素、甲氨蝶呤、亚叶酸钙、巯基嘌呤、强的松、硫鸟嘌呤、长春新碱和pegaspargase以不同的方式阻止癌细胞的生长，要么通过杀死细胞，要么通过阻止细胞分裂，或者通过阻止它们传播。本试验还将研究混合表型急性白血病(MPAL)和播散性B淋巴母细胞淋巴瘤(B- lly)患者接受高风险ALL化疗后的预后。本研究的总体目标是了解在高危b细胞急性淋巴母细胞白血病(HR B-ALL)中加入inotuzumab ozogamicin是否能维持或改善预后。研究的第一部分包括前两个阶段的治疗:诱导和巩固。这部分将收集关于白血病的信息，以及初始治疗的效果，以便将患者分为巩固后治疗组。 On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

资源和链接

电话:1 - 877 - mda - 6789

clinicaltrials.gov NCT编号：NCT03959085