NL-OMON28605尚未招募不适用
Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse; A randomized phase II study.
Stichting Hemato-Oncologie Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age 18 - 70 years inclusive;
- •2. First or second relapse of precursor B-ALL or T-ALL (including Philadelphia chromosome or BCR-ABL positive ALL);
- •3. Duration of last complete remission at least 6 months;
- •4. WHO performance status 0, 1, or 2;
- •5. Negative pregnancy test at inclusion if applicable;
- •6. Written informed consent.
排除标准
- •1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma;
- •2. Acute undifferentiated leukemia (AUL);
- •3. Treatment with alemtuzumab at any time prior to registration;
- •4. Intolerance of exogenous protein administration;
- •5. Central nervous system (CNS) leukemia (appendix A);
- •6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease);
- •7. Severe pulmonary dysfunction (CTCAE grade III-IV);
- •8. Severe neurological or psychiatric disease;
- •9. Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times normal level);
- •10. Significant renal dysfunction (serum creatinine >= 3 times normal level);
- •11. Patients with active, uncontrolled infections;
- •12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration;
- •13. Patients known to be HIV-positive;
- •14. Patient is a lactating woman;
- •15. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究者
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