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Sponsored by: |
University Hospital, Strasbourg, France |
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Information provided by: | University Hospital, Strasbourg, France |
ClinicalTrials.gov Identifier: | NCT00328029 |
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.
Condition | Intervention | Phase |
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Signs and Symptoms, Respiratory |
Drug: busulfan Procedure: respiratory function tests, before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). Procedure: pharmacokinetics, done during the treatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population |
Estimated Enrollment: | 35 |
Study Start Date: | February 2006 |
Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Patrick Lutz, MD | 3.33.88.12.80.90 | patrick.lutz@chru-strasbourg.fr |
Contact: Natacha Entz-Werle, MD | 3.33.88.12.80.99 | natacha.entz-werle@chru-strasbourg.fr |
France | |
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre | Recruiting |
Strasbourg, France, 67098 | |
Contact: Patrick Lutz, MD 3.33.88.12.80.90 patrick.lutz@chru-strasbourg.fr | |
Contact: Natacha Entz-Werle, MD 3.33.88.12.80.99 natacha.entz-werle@chru-strasbourg.fr | |
Principal Investigator: Patrick Lutz, MD | |
Sub-Investigator: Natacha Entz-Werle, MD | |
Sub-Investigator: Nadine COJEAN, MD | |
Sub-Investigator: Sophie BAYART, MD | |
Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil | Recruiting |
Strasbourg, France, 67091 | |
Contact: Charloux Anne, MD 3.33.88.11.61.22 anne.charloux@chru-strasbourg.fr | |
Contact: Oswald Monique, MD 3.33.88.11.68.61 monique.oswald@chru-strasbourg.fr |
Study Director: | Patrick Lutz, MD | Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre |
Study ID Numbers: | 2999 |
Study First Received: | May 18, 2006 |
Last Updated: | February 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00328029 |
Health Authority: | France: Ministry of Health |
Busulfan pharmacokinetic respiratory function assessment Busulfan pharmacokinetic and respiratory function tests |
Signs and Symptoms Busulfan Signs and Symptoms, Respiratory |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |