ISRCTN00446029已完成未知
Treatment of acute lymphoblastic leukemia (ALL) in adults age 40 - 70 years inclusive with chemotherapy including a pre-induction course for rapid tumor load reduction and prolonged maintenance chemotherapy: 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 55 人开始时间: 2010年9月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 55
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 40 - 70 years inclusive
- •2. Primary previously untreated ALL*
- •3. WHO performance status 0, 1, or 2
- •4. Negative pregnancy test at inclusion if applicable
- •5. Written informed consent
- •*Patients with mediastinal mass defining the so-called T-lymphoblastic leukemia/lymphoma are eligible for this trial. ALL patients with Philadelphia chromosome - t(9;22) and variants - are also eligible for this trial. However, when an alternative trial for Philadelphia chromosome positive patients becomes available, patients should be included in that trial by preference.
排除标准
- •1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
- •2. Acute undifferentiated leukemia (AUL)
- •3. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
- •4. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV)
- •5. Severe neurological or psychiatric disease
- •6. Significant hepatic dysfunction (serum bilirubin or transaminases = 3 times normal level) except when caused by leukemic infiltration
- •7. Significant renal dysfunction (serum creatinine = 3 times normal level after rehydration and correction of hyperuricemia)
- •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. History of anthracycline use exceeding a cumulative dose of 300 mg/m2 doxorubicin (or its biological equivalent)
- •10. Active, uncontrolled infections
- •11. Patient known to be HIV-positive
研究者
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