A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemothe
A phase III clinical trial evaluating efficacy and safety of minimal residual disease-based risk stratification for children with acute myeloid leukemia, incorporating a randomized study of gemtuzumab ozogamicin in combination with post-induction chemothe
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一项评估基于微小残留病风险分层对急性髓性白血病儿童的疗效和安全性的 III 期临床试验，其中纳入了吉妥珠单抗奥佐米星联合诱导后化疗的随机研究
DOI：
10.1093/jjco/hyac105
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发表时间：
2022
影响因子：
2.4
通讯作者：
Saito
中科院分区：
文献类型：
--
作者：
Tomizawa Daisuke;Tsujimoto Shin-ichi;Tanaka Shiro;Matsubayashi Jun;Aoki Takahiro;Iwamoto Shotaro;Hasegawa Daisuke;Nagai Kozo;Nakashima Kentaro;Kawaguchi Koji;Deguchi Takao;Kiyokawa Nobutaka;Ohki Kentaro;Hiramatsu Hidefumi;Shiba Norio;Terui Kiminori;Saito
本研究的目的是建立一个治疗与适当的强度为儿童（诊断时<16岁）伴新发急性髓细胞白血病（不包括与唐氏综合征相关的急性早幼粒细胞白血病和髓性白血病），根据基于复发性白血病细胞遗传学异常和流式细胞术的风险分层，初始诱导化疗结束时的细胞计数微小残留病，并验证吉妥珠单抗（GO）联合诱导后化疗对非低风险（非LR）患者。这项III期研究的主要终点是3年无病生存率，将在非LR（中危和高危[HR]）患者的GO和非GO组之间进行比较。所有HR患者将在首次缓解时分配接受异基因造血干细胞移植。本试验已在日本临床试验注册中心注册（jRCTs041210015）。
The purpose of this study is to establish a treatment with appropriate intensity for children (<16 years old at diagnosis) withde novoacute myeloid leukemia (excluding acute promyelocytic leukemia and myeloid leukemia associated with Down syndrome) according to a risk stratification based on recurrent leukemic cytogenetic abnormalities and flow-cytometric minimal residual disease at end of initial induction chemotherapy and to validate the safety and efficacy of gemtuzumab ozogamicin (GO)-combined post-induction chemotherapy for the non-low-risk (non-LR) patients. The primary endpoint of this phase III study is three-year disease-free survival rate, which will be compared between the GO and non-GO arms of the non-LR (intermediate-risk and high-risk [HR]) patients. All HR patients will be allocated to allogeneic hematopoietic stem cell transplantation in first remission. This trial has been registered at the Japan Registry of Clinical Trials (jRCTs041210015).