ISRCTN51564734已完成不适用
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.
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)0 个研究点目标入组 330 人开始时间: 2006年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Newly diagnosed patients with chronic myeloid leukemia (CML) in first chronic phase 2. Presence of Philadelphia chromosome or bcr-abl rearrangement
- •3. Age 18-65 years inclusive
- •4. World Health Organization (WHO) performance status 5. Written informed consent
排除标准
- •1. CML in accelerated phase or blastic crisis as defined by the WHO criteria
- •2. Hepatic dysfunction (serum bilirubin >/= 2 x upper limit of normal [ULN], and/or alanine aminotransferase [ALAT] >/= 4 x ULN, and/or aspartate aminotransferase [ASAT >/= 4 x ULN)
- •3. Renal dysfunction (creatinine >/= 200 µmol/l or 2.3 mg/dl)
- •4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II-IV)
- •5. Severe pulmonary or neurological disease
- •6. Pregnant or lactating females
- •7. 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
- •8. Patients known to be human immunodeficiency virus (HIV)-positive
- •9. Patients with active, uncontrolled infections
- •10. Previous treatment other than hydroxyurea for 11. Male and female patients of reproductive potential who are not practicing effective means of contraceptio
研究者
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