Bone Marrow Transplant InfectionRESPPEDHEMNCT02032381
Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
A study testing late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. in people with Bone Marrow Transplant Infection and Bronchiolitis Obliterans, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bone Marrow Transplant Infection, Bronchiolitis Obliterans, Chronic Respiratory Insufficiency
- What is being tested?
- late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to 30 Mar 2020
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: from birth to 18 years
- Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
- Affiliation to a social security scheme
Who cannot join
- non exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.
Read the detailed description
It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.
All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.
The inclusion will be done during two years and children will be following during three years.
The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.
- Conditions
- Bone Marrow Transplant Infection, Bronchiolitis Obliterans, Chronic Respiratory Insufficiency, Organizing Pneumonia, Pulmonary Cytolytic Thrombi
- Being tested
- late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.
- Keywords
- non infectious pulmonary complications after hematopoietic cell transplant, functional respiratory test and exercise test, thoracic tomodensitometry
- Medical subject headings
- Bronchiolitis Obliterans, Organizing Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.Other
| Study group | Role | What they receive |
|---|---|---|
| allogeneic hematopoietic stem cell | Other | The eligible population for this study will consist of all children under 18 years who received allogeneic hematopoietic stem cell and evaluate of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. Receives: Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of belated non-infectious pulmonary complications
Measured: 3 years
Secondary outcomes (3)
Presence of risk factors for belated non-infectious pulmonary complications
Measured: 3 years
Survival three years
Measured: 3 years
Severity of respiratory disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone Marrow Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Houdouin Véronique, MD PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032381
- Sponsor's protocol ID
- P120137
- Other IDs
- 2013-A00966-39
- Acronym
- RESPPEDHEM
- Status last verified
- Apr 2020
- First submitted
- 9 Dec 2013
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Houdouin V, Feghali H, Boileau S, Guinot M, Reix P, Pages J, Crepon SG, Delclaux C. Prospective Evaluation of Cardiorespiratory Fitness After Hematopoietic Stem Cell Transplantation in Children. Pediatr Pulmonol. 2025 May;60(5):e70994. doi: 10.1002/ppul.70994.
PubMed 40371796Houdouin V, Dubus JC, Crepon SG, Rialland F, Bruno B, Jubert C, Reix P, Pasquet M, Paillard C, Adjaoud D, Schweitzer C, Le Bourgeois M, Pages J, Yacoubi A, Dalle JH, Bergeron A, Delclaux C. Late-onset pulmonary complications following allogeneic hematopoietic cell transplantation in pediatric patients: a prospective multicenter study. Bone Marrow Transplant. 2024 Jun;59(6):858-866. doi: 10.1038/s41409-024-02258-7. Epub 2024 Mar 7.
PubMed 38454132
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
- ClinicalTrials.gov ID
- NCT02032381
- Acronym / sponsor ID
- RESPPEDHEM / P120137
- Conditions
- Bone Marrow Transplant Infection, Bronchiolitis Obliterans, Chronic Respiratory Insufficiency, Organizing Pneumonia, Pulmonary Cytolytic Thrombi
- Keywords
- non infectious pulmonary complications after hematopoietic cell transplant, functional respiratory test and exercise test, thoracic tomodensitometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 10 Jan 2014 (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.
Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.
Detailed description
It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.
All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.
The inclusion will be done during two years and children will be following during three years.
The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic hematopoietic stem cell | Other | Other: late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.The eligible population for this study will consist of all children under 18 years who received allogeneic hematopoietic stem cell and evaluate of late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age: from birth to 18 years
- Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
- Affiliation to a social security scheme
Key exclusion criteria (1 listed)
- non exclusion criteria
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 |
|---|---|---|
| late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. | Other | allogeneic hematopoietic stem cell |
Primary outcome
Presence of belated non-infectious pulmonary complications
Time frame: 3 years
3 secondary outcomes
Presence of risk factors for belated non-infectious pulmonary complications
Time frame: 3 years
Survival three years
Time frame: 3 years
Severity of respiratory disease
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 40371796Houdouin V, Feghali H, Boileau S, Guinot M, Reix P, Pages J, Crepon SG, Delclaux C. Prospective Evaluation of Cardiorespiratory Fitness After Hematopoietic Stem Cell Transplantation in Children. Pediatr Pulmonol. 2025 May;60(5):e70994. doi: 10.1002/ppul.70994.
- Derived from this study: PubMed 38454132Houdouin V, Dubus JC, Crepon SG, Rialland F, Bruno B, Jubert C, Reix P, Pasquet M, Paillard C, Adjaoud D, Schweitzer C, Le Bourgeois M, Pages J, Yacoubi A, Dalle JH, Bergeron A, Delclaux C. Late-onset pulmonary complications following allogeneic hematopoietic cell transplantation in pediatric patients: a prospective multicenter study. Bone Marrow Transplant. 2024 Jun;59(6):858-866. doi: 10.1038/s41409-024-02258-7. Epub 2024 Mar 7.
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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.
Houdouin Véronique, MD PHD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells. in people with Bone Marrow Transplant Infection and Bronchiolitis Obliterans, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of belated non-infectious pulmonary complications (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02032381, which also lists 2 linked publications.
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 29 Apr 2020.