Vinblastine Versus Oral Hydroxiurea in Newly Diagnosed AML With Hyperleukocytosis: a Phase 2 Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The proportion of patients with a significant reduction in the number of leukocytes by complete blood count
研究概览
简要总结
Vinblastine can leukoreduce patients with newly diagnosed AML and hyperleukocytosis but clinical trials are lacking.
详细描述
This phase 2 trial will explore the efficacy of a single dose of vinblastine (6mg/m2) to leukoreduce patients with newly diagnosed AML and hyperleukocytosis. Patients will be allocated 1:1 into two groups: intravenous single dose vinblastine or oral hydroxiurea (50mg/kg/day until response or induction chemotherapy). Effective leukoreduction and safety parameters will be compared.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Both genders
- •Diagnosis of non-M3 AML by the WHO 2016 diagnostic criteria
- •Patients eligible and not eligible for transplant
- •Patients eligible and not eligible for intensive treatment
- •AML secondary to treatment or associated to myelodisplasia
- •Leukocytes ≥50x106/L
- •Not being able to receive chemotherapy in the next two days
排除标准
- •AML with PMP/RAR-alfa translocation t(15;17)
- •Poor functional status (ECOG>2)
- •Active infection
研究组 & 干预措施
Intravenous Vinblastine
Single dose intravenous vinblastine (6mg/m2) in bolous.
干预措施: Vinblastine (Drug)
Oral Hydroxiurea
Patient will recieve oral hydroxiurea at a dose of 50mg/kg/day until response or administration of induction chemotherapy
干预措施: Hydroxyurea capsules (Drug)
结局指标
主要结局
The proportion of patients with a significant reduction in the number of leukocytes by complete blood count
时间窗: 2 days
The proportion of patients with a reduction in the number of leukocytes higher than 50% by complete blood count at 48 hours after the intervention.
次要结局
- Time to achieve a significant reduction in leukocyte count by complete blood count(5 days)
- Description of daily leukocytes by complete blood count after intervention(5 days)
研究者
David Gomez Almaguer
Head of Hematology Department
Hospital Universitario Dr. Jose E. Gonzalez