NCT00199186Unknown2 期
A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家开始时间: 2002年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
- 主要终点
- Remission rate after induction therapy
研究概览
简要总结
The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Age > 55 years (biological age)
- •Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)
- •Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia
- •Only pre-phase chemotherapy prior to study start
- •World Health Organization (WHO) status 0, 1 or 2
- •Voluntary written informed consent
排除标准
- •Creatinine levels more than 2 x the upper limit of normal (ULN)
- •Total serum bilirubin more than 1.5 x the ULN
- •AST (SGOT) or ALT (SGPT) more than 5 x the ULN
- •Any other prior antineoplastic treatment except for pre-phase chemotherapy
- •Active central nervous system (CNS) leukemia
- •New York Heart Association (NYHA) grade 3/4 cardiac disease
- •Active severe infection
- •Serious concomitant medical condition
- •Patients with a history of non-compliance to medical regimens
结局指标
主要结局
Remission rate after induction therapy
次要结局
- Mortality rate during induction
- Severe adverse events during induction
- Efficacy of salvage therapy after crossover
- Levels of minimal residual disease
- Incidence of relapse
- Remission duration
- Disease free survival
- Overall survival
- Frequency of point mutations in the BCR-ABL gene
研究者
研究点 (2)
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