ISRCTN78775328已完成不适用
Feasibility study using repeated intensive chemotherapy courses for patients with primary acute lymphoblastic leukemia in adults age 18 - 39 years inclusive: A phase II multicentre study
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)0 个研究点目标入组 50 人开始时间: 2010年9月6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
- 50
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. Age 18 - 39 years inclusive
- •2. Primary previously untreated ALL (including Philadelphia chromosome or BCR-ABL positive ALL)
- •3. WHO performance status 0, 1, or 2
- •4. Negative pregnancy test at inclusion if applicable
- •5. Written informed consent
排除标准
- •1. Mature B-cell ALL
- •2. Acute undifferentiated leukemia
- •3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- •4. Severe pulmonary dysfunction (CTCAE grade III-IV)
- •5. Severe neurological or psychiatric disease
- •6. Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times normal level)
- •7. Significant renal dysfunction (serum creatinine = 3 times normal level)
- •8. History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma
- •9. Active, uncontrolled infections
- •10. Patient known to be HIV-positive
- •11. Patient is a lactating woman
- •12. Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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