Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328029
Status:
UNKNOWN
Last Update Posted:
2009-02-25
First Post:
2006-05-18
Brief Title:
Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None