Estudo da eficácia do Nilotinibe Concomitante à Quimioterapia no Tratamento de Pacientes Com Leucemia linfoblástica Aguda Filadélfia Positiva recém-diagnosticada
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 主要终点
- Complete remission
研究概览
简要总结
Patients with acute lymphoblastic leukemia and positivity for the breakpoint cluster region-Abelson murine leukemia (BCR-ABL) protein or the Philadelphia chromosome have a poor prognosis with standard chemotherapy. The prognosis seemed to improve following the adition of imatinibe, a BCR-ABL inhibitor, to the treatment but still a substantial amount of patients relapse or progress during treatment.
Nilotinib is a BCR-ABL inhibitor more potent than imatinib. It has been shown to be effective against most of the cells that bear mutations of the BCR-ABL protein leading to resistance to imatinibe.
The investigators' hypothesis is that the addition of nilotinib to a standard chemotherapy for acute lymphoblastic leukemia (ALL) will translate into more rapid BCR-ABL reduction and effectiveness against imatinib-resistant clones leading to less relapses and better survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Acute Lymphoblastic Leukemia (ALL)
- •BCR-ABL positive positive by PCR (central Lab)
- •No previous treatment for ALL except for corticoids and cyclophosphamide less than 600 mg/m2
- •Must be able to swallow tablets
- •Lab results within normal limits (Potassium, Calcium, Magnesio, Phosphorus, Transaminases, Alkaline Phosphatase, Bilirrubine, Amylase, Lypase)
排除标准
- •Heart disease
- •Interval QTc Fridericia > 480 msec
- •Coumadin use
- •Pregnancy
- •Previous medical history of etilism or/and pancreatic disease
研究组 & 干预措施
nilotinib
single arm study
干预措施: Nilotinib (Drug)
结局指标
主要结局
Complete remission
时间窗: Day + 21 and Day + 41
次要结局
- Toxicity(Three times a week for the first 40 days than once weekly for the next 9 months than monthly for the next 2.1 years)
- Molecular remission(Every three months until three years)
- Overall Survival(Three years)
研究者
Rony Schaffel
MD, PhD
Universidade Federal do Rio de Janeiro