Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive Minimal Residual Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Hospital stay
研究概览
简要总结
Various drugs have been added to different treatment regimens in order to improve the response rate in patients with Acute Lymphoblastic Leukemia, however, it has been shown that adding Bortezomib to the relapsing regimen improves the proportion of second complete remissions without increasing chemotherapy toxicity. Therefore, proteasome inhibitors can drastically modify the prognosis of patients, since their synergy with drugs such as steroids has positioned them as an attractive strategy.
详细描述
Mortality associated with leukemia has decreased due to the use of various chemotherapy combinations, the addition of new agents, or the chemical modification of existing drugs. Despite advances in treatment, the prognosis in the adult population continues to be unfavorable. About 25% of the patients will be refractory to the first treatment regimen and the rest will have a disease-free survival below 40%. The chemotherapy intensity reduction strategy based on risk stratification according to Minimal Residual Disease (MRD) is a strategy used by various pediatric centers in order to detect patients at high risk of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmatory diagnosis of Acute Lymphoblastic Leukemia relapsed to bone marrow described with more than 5% blasts in bone marrow at any stage of treatment or positivity of minimal residual disease at any stage of treatment.
- •Patients who have signed their informed consent from the institution for hospitalization, and accepted the performance of the bone marrow study, and the administration of chemotherapy.
排除标准
- •Patients with a diagnosis of phenotypic leukemia or bilinear leukemia
- •Patients treated only with palliative regimen or transfusion support
- •Patients without the administration of prophylaxis to the central nervous system by intrathecal chemotherapy
- •Patients with lymphoblastic leukemia with a positive Philadelphia chromosome
- •Patients with severe comorbidities may put treatment therapy at risk.
- •Patient with a history of cardiac toxicity or arrhythmias associated with treatment
研究组 & 干预措施
Bortezomib Treatment Group
Each patient will receive their standard chemotherapy treatment for patients with relapsed Acute Lymphoblastic Leukemia based on the HyperCVAD scheme in combination with Bortezomib for a period of 12 weeks. Each chemotherapy cycle will be monitored by the health team corresponding to the Hematology service and the principal investigator.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Hospital stay
时间窗: 3 months
Time in which patients stay in the Hospital before discharge
Leukocytes count
时间窗: 3 months
Number of leukocytes found in peripheral blood at the end of each chemotherapy cycle
Survival Outcome
时间窗: 3 months
The event in which patient is discharge from Hospital stay.
Platelets count
时间窗: 3 months
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Date of Remission
时间窗: 3 month
Time in which the patient completes remission
次要结局
未报告次要终点
研究者
Christian Omar Ramos-Peñafiel, MD, PhD
Principal Investigator
Hospital General de Mexico