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临床试验/NCT00458848
NCT00458848已完成2 期

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Gruppo Italiano Malattie EMatologiche dell'Adulto124 个研究点 分布在 1 个国家目标入组 470 人开始时间: 2004年10月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
470
试验地点
124
主要终点
Percentage of Participants Reaching Disease Free Survival

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia.

Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of Participants Reaching Disease Free Survival

时间窗: At 60 months

次要结局

  • Percentage of Participants Reaching Overall Survival(At 60 months)
  • Number of Patients Reaching Complete Hematological Response After Induction Therapy(At the end of induction, day +50)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (124)

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