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临床试验/NCT00328029
NCT00328029Unknown2 期

Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population

University Hospital, Strasbourg, France4 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2006年7月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
发起方
入组人数
35
试验地点
4
主要终点
Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan

研究概览

简要总结

Recently, several conditioning regimens did not include total body irradiation (TBI) anymore, especially in the case of young children due to cognitive sequelae and late effects on growth and height. Thus, such effective chemotherapy conditioning regimens were developed to avoid these complications. Busulfan is one of the major drugs used in these treatments, but, is also administered in high dose chemotherapy followed by autograft. In both situations, long term pulmonary side effects were diagnosed in a few cases. Even if the occurrence is not very frequent, the clinical management is a real challenge regarding the reduced quality of life and life expectancy of these patients. Up to now, no correlation was done between respiratory sequelae and busulfan pharmacokinetics. Hence, in the investigators' pediatric onco-hematological unit, a prospective study will begin and last three years to assess the respiratory side effects due to busulfan and their potential links with individual drug pharmacokinetic measures. These results will be compared to patients treated with TBI during the same period of time.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above 3 years old treated by busulfan or TBI in their conditioning regimens before allograft or busulfan in high dose chemotherapeutic regimens followed by autograft will be included after parents informed assent.

排除标准

  • 未提供

结局指标

主要结局

Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan

时间窗: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).

次要结局

  • Comparison to respiratory side effect frequency with TBI conditioning regimen(before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).)
  • Busulfan pharmacokinetics(after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h ; 3 h after 2nd Busulfan taken ; 3 hours after 3rd Busulfan taken ; 3 h after 4st Busulfan taken ;3 h after 5st Busulfan taken ;3 h after 6st Busulfan taken)
  • Establish a potential link between respiratory side effects and busulfan pharmacokinetics

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other

研究点 (4)

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