Informations générales (source: ClinicalTrials.gov)
Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population
Interventional
Phase 2
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
juillet 2006
juin 2012
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL PEDIATRIE REEDUCATION BULLION | Patrick Lutz, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil - 67091 - Strasbourg - France | Charloux Anne, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.