NCT00219726已完成2 期
Phase II Trial to Study the Tolerability and the Effectiveness of Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase in Relapse After Allogeneic Stem Cell Transplantation
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- - to assess the tolerability of Imatinib given at a daily dose of 400mg
研究概览
简要总结
The aim of this phase II trial is asses the tolerability and the effectiveness of imatinib in patients with chronic myelogenous leukemia in chronic phase who are in relapse after stem cell transplantation.
详细描述
Patients will received Imatinib at a dose of 400mg daily. The tolerability of Imatinib given at a daily dose of 400mg will be assessed. The hematologic, cytogenetic and molecular responses will be evaluated at various check points.
Donor/recipient chimerism during Imatinib therapy will be assessed. Survival will be estimated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CML Ph+ (assessed by cytogenetic or FISH)
- •Age ≥ 18 year at inclusion
- •PS grade 0 to 2 (ECOG)
- •previous allogeneic stem cell transplantation
- •molecular, cytogenetic or haematological relapse in chronic phase after transplantation
- •Immune therapy for graft versus host disease stopped within 2 months from inclusion
- •Adequate and organ function, defined as the following: total bilirubin <3x uln, sgpt <3x uln, creatinine <2x uln.
- •informed consent sign up
排除标准
- •Age less than 18 y
- •accelerated or blastic phase
- •previous therapy with imatinib
- •active malignancy other than CML or non-melanoma cancer of the skin
- •current treatment with another investigational agent
结局指标
主要结局
- to assess the tolerability of Imatinib given at a daily dose of 400mg
- to evaluate the hematologic, cytogenetic and molecular responses at various check points.
次要结局
- - to assess donor/recipient chimerism during Imatinib therapy
- - to evaluate the survival
研究者
研究点 (2)
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