A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapse of Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 35
- 主要终点
- Number of Participants With Dose Limiting Toxicities as a Measure of Safety and Tolerability
研究概览
简要总结
This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).
详细描述
This study will utilize Marqibo® as a replacement for standard vincristine in combination with chemotherapy for children with relapsed ALL. The hypothesis is that the incorporation of Marqibo® with combination chemotherapy will be safe and feasible. In the context of this pilot study, overall outcomes and efficacy will be a secondary objective. It is hypothesized that data from this combination may show improved efficacy including, complete remission (CR), minimal residual disease (MRD) negativity, and progression free survival (PFS) rates and safety (i.e., neurotoxicity) in comparison to outcomes in historical regimens, including the UK ALL R3 with standard vincristine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A: Marqibo and UK ALL R3 backbone
- Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22.
- Dexamethasone orally twice daily on days 1-5 and 15-19.
- Mitoxantrone: given by intravenous (IV) infusion on days 1 and 2.
- PEG-asparaginase: given as an injection into the muscle on says 3 and 17.
- Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
干预措施: Marqibo (Drug)
Cohort B: Marqibo and lower intensity UK ALL R3 backbone
- Marqibo®: given by intravenous (IV) infusion on days 1, 8, 15 and 22.
- Dexamethasone orally twice daily on days 1-5 and 15-19.
- PEG-asparaginase: given as an injection into the muscle on days 3 and 17.
- Methotrexate IT: given intrathecally (used to treat the brain and spinal cord and is given using a needle inserted into the spinal canal) on days 1 and 8.
干预措施: Marqibo (Drug)
Cohort C: Marqibo and maintenance regimen
- Marqibo®: given by intravenous (IV) infusion on day 1
- Dexamethasone orally twice daily on days 1-5
- Methotrexate: given orally on days 1 and 8
- Mercaptopurine: given orally daily on days 1-13
干预措施: Marqibo (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicities as a Measure of Safety and Tolerability
时间窗: 9 weeks
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability at different dose levels of Marqibo. Dose Level 1 = 1.5 mg/m\^2. Dose Level 2 = 2.0 mg/m\^2. Cohort A and B accrued at both Dose Levels. Cohort C accrued only at Dose Level 2.
次要结局
未报告次要终点