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首页> 美国卫生研究院文献>Blood >Clinical Trials and Observations: Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801
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Clinical Trials and Observations: Nelarabine induces complete remissions in adults with relapsed or refractory T-lineage acute lymphoblastic leukemia or lymphoblastic lymphoma: Cancer and Leukemia Group B study 19801

机译：临床试验和观察：Nelarabine诱导成人T谱系复发或难治性T淋巴细胞急性白血病或淋巴母细胞淋巴瘤完全缓解：癌症和白血病B组研究19801

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Nelarabine (506U78) is a soluble pro-drug of 9-β-d-arabinofuranosylguanine (ara-G), a deoxyguanosine derivative. We treated 26 patients with T-cell acute lymphoblastic leukemia (T-ALL) and 13 with T-cell lymphoblastic lymphoma (T-LBL) with nelarabine. All patients were refractory to at least one multiagent regimen or had relapsed after achieving a complete remission. Nelarabine was administered on an alternate day schedule (days 1, 3, and 5) at 1.5 g/m2/day. Cycles were repeated every 22 days. The median age was 34 years (range, 16-66 years); 32 (82%) patients were male. The rate of complete remission was 31% (95% confidence interval [CI], 17%, 48%) and the overall response rate was 41% (95% CI, 26%, 58%). The principal toxicity was grade 3 or 4 neutropenia and thrombocytopenia, occurring in 37% and 26% of patients, respectively. There was only one grade 4 adverse event of the nervous system, which was a reversible depressed level of consciousness. The median disease-free survival (DFS) was 20 weeks (95% CI, 11, 56), and the median overall survival was 20 weeks (95% CI, 13, 36). The 1-year overall survival was 28% (95% CI, 15%, 43%). Nelarabine is well tolerated and has significant antitumor activity in relapsed or refractory T-ALL and T-LBL.
机译：Nelarabine（506U78）是一种9-β-d-阿拉伯呋喃糖基鸟嘌呤（ara-G）（一种脱氧鸟苷衍生物）的可溶性前药。我们治疗了26例T细胞急性淋巴细胞白血病（T-ALL）患者和13例含奈拉拉滨的T细胞淋巴母细胞瘤（T-LBL）。所有患者均对至少一种多药治疗方案无效，或在完全缓解后已复发。 Nelarabine每隔一天（第1、3和5天）的剂量为1.5 g / m 2 /天。每22天重复一次循环。中位年龄为34岁（范围16-66岁）； 32名（82％）患者为男性。完全缓解率为31％（95％置信区间[CI]，17％，48％），总缓解率为41％（95％CI，26％，58％）。主要毒性为3级或4级中性粒细胞减少症和血小板减少症，分别发生在37％和26％的患者中。神经系统只有4级不良事件，这是可逆的意识低落。中位无病生存期（DFS）为20周（95％CI，11，56），中位总生存期为20周（95％CI，13，36）。 1年总生存率为28％（95％CI，15％，43％）。 Nelarabine具有良好的耐受性，并且在复发或难治的T-ALL和T-LBL中具有显着的抗肿瘤活性。

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