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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| busulfan | Drug | 5mg/kg/day (oral route : 4 doses/day for 4 days) | ||
| respiratory function tests | Procedure | respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). |
| |
| pharmacokinetics, done during the treatment | Procedure | 12 blood collections :
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan | before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lutz, MD | Contact | 3.33.88.12.80.90 | patrick.lutz@chru-strasbourg.fr | |
| Natacha Entz-Werle, MD | Contact | 3.33.88.12.80.99 | natacha.entz-werle@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Lutz, MD | Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil | Recruiting | Strasbourg | 67091 | France |
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| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D012143 | Respiratory Physiological Phenomena |
| D014182 | Transplantation, Autologous |
| D010599 | Pharmacokinetics |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Establish a potential link between respiratory side effects and busulfan pharmacokinetics |
| Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre | Recruiting | Strasbourg | 67098 | France |
|
| D008698 |
| Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D008660 | Metabolism |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |