A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
研究概览
简要总结
Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone
详细描述
Patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be treated according to the another French Protocol while patients with Ph-ve ALL will be included in the "caelyx" protocol and randomly allocated to induction with VAD or with vadox-li-Peg (caelyx).
A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients.
Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine.
During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients.
Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age and older
- •ECOG performance </=2 or >/=3
- •VIH negative
- •Absence of previous ALL treatment
- •Informed consent signed
- •SGPT and Bilirubin < 4x upper limit of normal
- •Normal creatinine for age
- •cardiac state compatible with anthacyclin
排除标准
- •ALL with Philadelphia Chromosome
- •CML blasts crisis
- •Cardiac insufficiency and/ or left ventricular ejection fraction < 50%
- •Evolutive infection
- •Presence of other evolutifs cancer or ongoing treatment
- •mental status incompatible with inform consent
研究组 & 干预措施
doxorubicine
VAD
干预措施: Doxorubicine (Drug)
Doxorubicine pegylated
Doxorubicine pegylated 40 MG/M² J1
干预措施: Doxorubicine pegylated (Drug)
结局指标
主要结局
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
时间窗: 113 days
次要结局
- Hematological and cutaneous adverse evnts of both types of chemotherapy(113 days)
- Resistance to chemotherapy(113 days)
- Complete response rates(113 days)
- Economical study(113 days)
- Disease free and overall survival(4 months)