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临床试验/NCT00195871
NCT00195871Unknown2 期

A Multicenter, Phase 2 Study, to Evaluate Safety and Efficacy of an Acute Lymphoblastic Leukemia (ALL) Intensive Chemotherapy for Adult Lymphoblastic Lymphoma (LL).

Centre Henri Becquerel38 个研究点 分布在 2 个国家目标入组 155 人开始时间: 2004年2月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
155
试验地点
38
主要终点
Event free survival

研究概览

简要总结

The primary objective of this study is to evaluate the safety and the efficacy of an adult "acute lymphoblastic leukaemia" type chemotherapy in patients less than 60 years with lymphoblastic lymphoma. Treatment principle is based on an intensive induction and a delayed intensification.

详细描述

Lymphoblastic lymphomas (LL) are rare and represent less than 2% of the malignant non-Hodgkin lymphomas (NHL). The distinction between a LL and an acute lymphoblastic leukaemia (ALL) is difficult; it is arbitrarily based on the percentage of medullary blasts. Above 20% of blasts, it is an ALL. In both cases, the same type of cells is affected: the lymphoblast. Thus the LL were treated either as aggressive NHL or as ALL. The results of the various clinical studies, have shown a best efficacy of ALL type treatments(in terms of overall survival and disease free survival). These treatments are based on an induction phase with reinforced cyclophosphamide and L-asparaginase, and a re-use of the first drugs after consolidation (delayed intensification). The prognostic factors of ALL are now better defined, determining risk groups. According to these prognostic indicators, the allograft could be proposed in first complete remission. Indicators are biological (hyperleukocytosis, chromosomal abnormalities as t(4;11), t(9;22), t(1;19) translocations), clinical (central nervous system involvement), evolutive (salvage therapy needed to obtain complete remission), consideration of early response (cortico-sensibility and chemo-sensibility) and molecular responses (residual disease). On the other hand, the prognostic factors of LL are not well known. This study should permit to better define them. So the prognostic indicators of ALL, in this study, will be decisional for the indication of allograft. This treatment is based on a parallel currently recruiting adult patients with ALL (protocol GRAALL 2003).

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
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with lymphoblastic lymphoma.
  • Aged from 18 to 59 years.
  • Medullary blasts rate less than 20%
  • Non previously treated
  • With or without central nervous system or meningeal involvement.
  • No contra-indication to anthracyclines.
  • No contra-indication to intensive treatments
  • Negative HIV serology test
  • Negative pregnancy test for all female patients of childbearing potential.
  • Able to be regularly followed up.

排除标准

  • Evolutive cancer with the exception of non melanoma skin tumours or stage 0 (in situ) cervical carcinoma.
  • Prior treatment with chemotherapy.
  • Lymphoblastic Transformation of chronic myeloid leukaemia
  • Patient unable to be regularly followed-up.

结局指标

主要结局

Event free survival

时间窗: 2 y

次要结局

  • Disease Free Survival ; Complete response rate ; Overall Survival ; Progression rate; Relapse rate ; Central Nervous System or meningeal relapse rate ; medullary relapse rate ; toxicities.(2 y)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephane Lepretre

Principal Investigator

Centre Henri Becquerel

研究点 (38)

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