NCT00388895已完成2 期
Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
PETHEMA Foundation31 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 31
- 主要终点
- % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
研究概览
简要总结
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment
详细描述
Pilot phase II clinical trial, prospective, multicentric and opened
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old
- •Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
- •Performance status 0-2 (Appendix B); Is allowed performance status > 2 because of LLA
- •Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine < 1,5 mg/dl o Clearance creatinine > 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV > 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
- •Negative HIV serology
- •Written, oral or with witness informed consent. In patients < 18 years old must be signed written and legal representative informed consent.
- •No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.
排除标准
- •Other LLA variability
- •Previous history of coronary valvular, hypertensive cardiopathy illness
- •Chronic hepatic illness
- •Chronic respiratory insufficiency
- •Renal insufficiency not caused by LLA
- •Severe neurological problems not caused by LLA
- •Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
- •Pregnancy and women
- •Blastic crisis LMC
结局指标
主要结局
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
Discover the Glivec effect over ERM during consolidation treatment and alter transplant
次要结局
未报告次要终点
研究者
研究点 (31)
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