NCT05519579招募中2 期
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
研究概览
简要总结
Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia
- •Adequate renal and hepatic function
- •Negative for HIV
- •Negative serum pregnancy test, if applicable
排除标准
- •Active CNS involvement by ALL
- •Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)
- •Contraindication to receive intrathecal methotrexate
- •Prior treatment with blinatumomab
- •Active malignancy other than ALL
- •Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
研究组 & 干预措施
Intrathecal chemotherapy before blinatumomab
Experimental
干预措施: Blinatumomab (Drug)
Intrathecal chemotherapy before blinatumomab
Experimental
干预措施: Methotrexate (Drug)
结局指标
主要结局
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
时间窗: 28 days after first infusion
Record occurrence and severity of neurotoxicity based on CTCAE criteria
次要结局
- Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy(28 days after first infusion)
- Number of participants with a response of complete remission and MRD negativity at the end of cycle 1(28 days after first infusion)
研究者
研究点 (2)
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