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Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population

24. februar 2009 opdateret af: University Hospital, Strasbourg, France

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Tegn og symptomer, luftveje

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Frankrig
- - Strasbourg, Frankrig, 67091
    - Rekruttering
    - Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil
    - Kontakt:
      
      Charloux Anne, MD
      
      Telefonnummer: 3.33.88.11.61.22
      
      E-mail: anne.charloux@chru-strasbourg.fr
    - Kontakt:
      
      Oswald Monique, MD
      
      Telefonnummer: 3.33.88.11.68.61
      
      E-mail: monique.oswald@chru-strasbourg.fr
  - Strasbourg, Frankrig, 67098
    - Rekruttering
    - Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
    - Kontakt:
      
      Patrick Lutz, MD
      
      Telefonnummer: 3.33.88.12.80.90
      
      E-mail: patrick.lutz@chru-strasbourg.fr
    - Ledende efterforsker:
      
      Patrick Lutz, MD
    - Underforsker:
      
      Natacha Entz-Werle, MD
    - Kontakt:
      
      Natacha Entz-Werle, MD
      
      Telefonnummer: 3.33.88.12.80.99
      
      E-mail: natacha.entz-werle@chru-strasbourg.fr
    - Underforsker:
      
      Nadine COJEAN, MD
    - Underforsker:
      
      Sophie BAYART, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan Tidsramme: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).	before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).

Sekundære resultatmål

Resultatmål	Tidsramme
Comparison to respiratory side effect frequency with TBI conditioning regimen Tidsramme: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).	before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Busulfan pharmacokinetics Tidsramme: 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	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Strasbourg, France

Efterforskere

Studieleder: Patrick Lutz, MD, Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Forventet)

1. januar 2012

Studieafslutning (Forventet)

1. juni 2012

Datoer for studieregistrering

Først indsendt

18. maj 2006

Først indsendt, der opfyldte QC-kriterier