A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Sanofi
- 主要终点
- Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
研究概览
简要总结
Primary Objective:
Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.
Secondary Objectives:
- Assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose.
- Measure the levels of immunoglobulin protein.
- Assess the impact of any immune response on safety and the duration of low white blood cell count.
详细描述
The total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older 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
sargramostim
Sargramostim is administered daily until the absolute neutrophil count (ANC) equals or exceeds 1500/mm^3 for 3 consecutive measurements or up to 42 days post-induction chemotherapy.
干预措施: sargramostim GZ402664 (Drug)
结局指标
主要结局
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
时间窗: 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months
次要结局
- Assessment of antibodies (antibody detection and antibody titers)(6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline up to 24 months)
- Assessment of immunoglobulin levels(6 months after 1st dose of sargramostim. If antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6 months until the antibodies level return to baseline or up to 24 months)
- Proportion of patients with adverse events(Up to 24 months)
- Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)(Up to 42 days after first day of sargramostim administration)