EUCTR2006-005694-21-DE进行中（未招募）不适用
AN OPEN LABEL PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF INDUCTION AND CONSOLIDATION THERAPY WITH DASATINIB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS AGED 55 YEARS AND OVER WITH PHILADELPHIA CHROMOSOME POSITIVE (PH+ OR BCR-ABL+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL).EWALL-PH-01 - EWA
CH-Versailles0 个研究点目标入组 55 人开始时间: 2007年10月15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
- 55
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
- •1. Male or female patients = 55 years
- •2. Philadelphia chromosome or BCR-ABL positive acute lymphoblastic leukaemia
- •3. Not previously treated except with corticosteroids (or single dose vincristine)
- •4. With or without documented CNS involvement
- •5. Signed written inform consent
- •6. Molecular evaluation for BCR-ABL done
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with ECOG status > 2
- •2. Patient previously treated with Tyrosine Kinase Inhibitors
- •3. Patients with QTc > 450 ms
- •4. Heart insufficiency NYHA grade III/IV, LEVF < 50% and or RF < 30%, myocardial
- •infarction within the past 6 months prior to study
- •5. Active secondary malignancy
- •6. Patients with active bacterial, viral or fungal infection
- •7. Known infection with HIV, Hepatitis B (except post vaccinal profile) or C
- •8. Treatment with any, other investigational agent or participating in another trial
- •within 30 days prior to entering this study
- •9. Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of normal and total bilirubin > 2 fold the institutional upper limit unless considered to be due to organ involvement by the leukemia
- •10. Concurrent severe diseases which exclude the administration of therapy
研究者
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