Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Impact of Imatinib on survival in elderly patients with Ph+ALL
研究概览
简要总结
ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation.
Duration of therapy : 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ph+ ALL patients
- •55 years or older
- •Signed written informed consent
排除标准
- •CML in transformation
- •Concomitant malignancy
- •Previous treatment by Imatinib
- •Severe organ condition
结局指标
主要结局
Impact of Imatinib on survival in elderly patients with Ph+ALL
次要结局
- Tolerance of Imatinib
- Complete remission rate
- Minimal Residual Disease after Imatinib treatment
- Leukemia free survival
- Impact of steroids given before starting chemotherapy
- Study of potential resistance mechanisums to Imatinib