EUCTR2005-003839-41-BE进行中（未招募）不适用
Imatinib in combination with Cytarabine as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia.A prospective randomized phase III study. - HOVON 78 CM
HOVON Foundation0 个研究点目标入组 330 人开始时间: 2007年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Newly diagnosed patients with CML in first chronic phase £ 2 months;
- •Presence of Philadelphia chromosome or bcr-abl rearrangement;
- •Age 18-65 years inclusive;
- •WHO performance status £ 2 (see appendix E);
- •Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •CML in accelerated phase or blastic crisis as defined by the WHO criteria (see appendix A).
- •Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N, and/or ASAT >= 4 x N);
- •Renal dysfunction (creatinine >= 200 mmol/l or 2.3 mg/dl);
- •Severe cardiac dysfunction (NYHA classification II-IV, see appendix F);
- •Severe pulmonary or neurologic disease;
- •Pregnant or lactating females;
- •Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
- •Patients known to be HIV-positive;
- •Patients with active, uncontrolled infections;
- •Previous treatment other than hydroxyurea <= 2 months or imatinib <= 1 month;
- •Male and female patients of reproductive potential who are not practicing effective means of contraception.
研究者
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