Signs and Symptoms, RespiratoryPhase 2NCT00328029
Respiratory Side Effects of Busulfan High Dose Chemotherapy in a Pediatric Population
A Phase 2 study testing busulfan, respiratory function tests and pharmacokinetics, done during the treatment in people with Signs and Symptoms, Respiratory, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Signs and Symptoms, Respiratory
- What is being tested?
- busulfan, respiratory function tests and pharmacokinetics, done during the treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Service d'Explorations Fonctionelles Respiratoires - Hôpital Civil
Strasbourg, 67091
Charloux Anne, MD, 3.33.88.11.61.22, anne.charloux@chru-strasbourg.fr
Oswald Monique, MD, 3.33.88.11.68.61, monique.oswald@chru-strasbourg.fr
- Recruiting
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
Strasbourg, 67098
Patrick Lutz, MD, 3.33.88.12.80.90, patrick.lutz@chru-strasbourg.fr
Natacha Entz-Werle, MD, 3.33.88.12.80.99, natacha.entz-werle@chru-strasbourg.fr
About this study
Official title: 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.
- Conditions
- Signs and Symptoms, Respiratory
- Being tested
- busulfan, respiratory function tests, pharmacokinetics, done during the treatment
- Keywords
- Busulfan, pharmacokinetic, respiratory function assessment, Busulfan pharmacokinetic and respiratory function tests
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
busulfanDrug
5mg/kg/day (oral route : 4 doses/day for 4 days)
respiratory function testsProcedure or surgery
Also called before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
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 treatmentProcedure or surgery
12 blood collections :
- after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h.
- 3 hours after 2nd taken of Busulfan
- 3 hours after 3rd taken of Busulfan
- 3 hours after 4th taken of Busulfan
- 3 hours after 5th taken of Busulfan
- 3 hours after 6th taken of Busulfan.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan
Measured: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Secondary outcomes (3)
Comparison to respiratory side effect frequency with TBI conditioning regimen
Measured: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Busulfan pharmacokinetics
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, RespiratoryStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Lutz, MD, Study director, Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328029
- Sponsor's protocol ID
- 2999
- Status last verified
- Feb 2009
- First submitted
- 18 May 2006
- Last updated
- 25 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Respiratory Functions After a Conditioning Regimen With Busulfan for Allograft or Autograft in a Unicenter Pediatric and Prospective Population
- ClinicalTrials.gov ID
- NCT00328029
- Acronym / sponsor ID
- 2999
- Conditions
- Signs and Symptoms, Respiratory
- Keywords
- Busulfan, pharmacokinetic, respiratory function assessment, Busulfan pharmacokinetic and respiratory function tests
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 19 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| busulfan5mg/kg/day (oral route : 4 doses/day for 4 days) | Drug | – |
| respiratory function testsAlso: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).respiratory function tests before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months). | Procedure or surgery | – |
| pharmacokinetics, done during the treatment12 blood collections : * after 1st Busulfan taken : t0; t0 + 30 mn; t0 + 1h; t0 + 2h ; t0 + 3h ; t0 + 4h ; t0 + 5 h. * 3 hours after 2nd taken of Busulfan * 3 hours after 3rd taken of Busulfan * 3 hours after 4th taken of Busulfan * 3 hours after 5th taken of Busulfan * 3 hours after 6th taken of Busulfan. | Procedure or surgery | – |
Primary outcome
Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan
Time frame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
3 secondary outcomes
Comparison to respiratory side effect frequency with TBI conditioning regimen
Time frame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).
Busulfan pharmacokinetics
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
Related trials for Signs and Symptoms, Respiratory
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Lutz, MD study director
Service de Pédiatrie Onco-Hématologie - Hôpital de Hautepierre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing busulfan, respiratory function tests and pharmacokinetics, done during the treatment in people with Signs and Symptoms, Respiratory, run by University Hospital, Strasbourg, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lutz, MD (3.33.88.12.80.90, patrick.lutz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of respiratory side effect frequency in the two years follow up of allograft or autograft treated with busulfan (time frame: before allograft or autograft and at several times in the follow up (3, 6, 12, 18 and 24 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009.