Bronchiolitis Obliterans SyndromeNCT03072849
Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation
An observational study of Bronchiolitis Obliterans Syndrome, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This study aims to determine whether or not early spirometric detection and management of obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can attenuate declining lung function, prevent the development of bronchiolitis obliterans, and improve patient outcomes following… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome
- What is being tested?
- Pulmonary function testing and FAM Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Sep 2020
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients undergoing allogenic hematopoietic stem cell transplant
Who may be able to join
- Diagnosis: Patients undergoing myeloablative allogenic hematopoietic stem cell transplant for any indication (both malignant and non-malignant) are eligible.
- Graft: Eligible patients will have one or more of the following donor stem cell sources:
- Bone marrow
- Placental blood (umbilical cord blood)
- Cytokine mobilized peripheral blood
- Eligible patients will have one of the following sources of donor stem cells:
Show all 14Show fewer
- HLA matched family member
- Partially matched family member (mismatched for a single HLA locus at A, B, C or DR)
- Fully HLA matched or partially mismatched unrelated marrow or peripheral blood stem cells (per institutional donor selection standards)
- HLA matched or partially mismatched (at least 4/6 match at A, B, DR) cord blood.
- Conditioning Regimen: Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible.
- Prior therapies: Patients undergoing stem cell transplant of any kind.
- Required laboratory parameters: Patients able to adequately perform pulmonary function testing per ATS/ERS guidelines, as determined by the enrolling investigator and trained respiratory therapists.
- The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained in accordance with the institutional policies approved by the U.S. Department of Health and Human Services. Informed consent must be signed prior to registration on study.
Who cannot join
- Subjects with a previous solid organ transplant.
- Recurrent or progressive malignancy requiring anti-cancer therapy.
- Subjects with evidence of underlying obstructive pulmonary disease prior to transplant (clinical history of asthma or baseline FEV1 <80% predicted with FEV1/FVC <80%).
- Known history of allergy or intolerance to Montelukast, Zafirleukast, Azithromycin, Erythromycin, Clarithromycin, Prednisone, or Sirolimus.
- Chronic supplemental oxygen requirement or hypoxemia <92% SpO2.
- Clinical asthma (variable and recurrent symptoms of airflow obstruction and airway hyper-responsiveness).
Show all 14Show fewer
- Pregnancy or nursing: All females of childbearing age must have a negative serum or urine pregnancy test <7 days before study drug administration.
- Chronic treatment with any inhaled steroid for >1 month in past three months.
- Treatment with montelukast or zafirukast for >1 month in past three months.
- Treatment with systemic steroids for >1 month in past three months.
- Treatment with any FDA non-approved study medication within the past four weeks. Off label treatment with FDA approved medication is allowed.
- Evidence of any viral, bacterial, or fungal infection involving the lung and not responding to appropriate treatment.
- Inability to perform pulmonary function testing (PFT), as determined by the enrolling investigator or PFT lab.
- Any condition that, in the opinion of the enrolling investigator, would interfere with the subject's ability to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
This study aims to determine whether or not early spirometric detection and management of obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can attenuate declining lung function, prevent the development of bronchiolitis obliterans, and improve patient outcomes following hematopoietic stem cell transplant.
Read the detailed description
Bronchiolitis obliterans syndrome (BOS) is an inflammatory condition of the lungs that leads to obstructive physiology, irreversible fibrosis of terminal bronchioles, and obliteration of the small airways. In both children and adults, the prevalence of BOS is approximately 6% in those with chronic graft-vs-host disease (cGVHD), although this may be a gross underestimation given current diagnostic guidelines. Once diagnosed, the prognosis is extremely unfavorable. BOS carries a mortality rate of approximately 40-60%, with a five year survival rate of 13%.
Early on, BOS is symptomatically silent. Once symptoms are present, there is a high likelihood of irreversible disease regardless of the combination of immune suppression used. Given these circumstances, early diagnosis is of utmost importance, and can be characterized by an isolated and subclinical decline in lung function. Recent studies have suggested that early decline in lung function on pulmonary function testing (PFT) may be representative of developing BOS.
Due to the lack of consistent screening and diagnostic criteria, many patients with evolving BOS elude a timely diagnosis, thereby jeopardizing their chance of survival. In response, several experts have recommended frequent PFT screening and a modified, less stringent set of diagnostic criteria with the goal of establishing earlier diagnosis and timely intervention.
Traditionally, treatment of BOS has included aggressive immunosuppression, leaving patients at risk for life-threatening invasive infections, multi-system co-morbidities, and the threat of lung transplantation. Recent studies have demonstrated that early management with agents such as inhaled corticosteroids (ICS), macrolides, and leukotriene receptor antagonists (LTRA) can lead to improvements in both lung function and clinical symptoms.
This study aims to evaluate the utility of frequent and routine pulmonary surveillance in pediatric patients who have undergone allogenic HSCT. Our prospective study design provides a novel framework for the implementation of standardized lung function screening every three months in the first two years following HSCT. With this, we hypothesize that standardized PFT screening will improve diagnostic sensitivity and allow for earlier intervention in patients with evolving airway obstruction and BO.
This study also aims to evaluate the efficacy of inhaled fluticasone, azithromycin, and montelukast (FAM therapy) in the management of early airflow obstruction in pediatric patients following allogenic HSCT. Early airflow obstruction is defined by pulmonary function testing (FEV1 decline of ≥10% predicted with a FVC <0.8). With this, we hypothesize that FAM therapy will attenuate the progression of airflow obstruction and improve lung function in those with irreversible airflow obstruction at one and two years when compared to historical controls.
- Conditions
- Bronchiolitis Obliterans Syndrome
- Being tested
- Pulmonary function testing, FAM Therapy
- Keywords
- Pediatrics, Airflow obstruction, Chronic graft-vs-host disease, Bronchiolitis obliterans syndrome
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary function testingProcedure or surgery
Also called PFT, Spirometry, Plethysmography, Diffusion capacity
Each enrolled patient will receive pulmonary function testing every three months. Pulmonary function testing includes spirometry, plethysmography, and diffusion capacity measurements.
FAM TherapyDrug
Also called Fluticasone (Inhaled), Azithromycin, Montelukast
All patients who have evidence of early airflow obstruction on pulmonary function testing will be started on FAM therapy. Early airflow obstruction is defined by a FEV1 decline of ≥10% predicted in addition to a FVC <0.8.
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Transplant Recipients | Pediatric patients ages 6-18 years who have received allogenic hematopoietic stem cell transplant for any reason. Receives: Procedure: Pulmonary function testing; Drug: FAM Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Change in lung function at 12 and 24 months post-HSCT
Measured: 2 years
Survival
Overall survival at 2 years post-HSCT
Measured: 2-4 years
Secondary outcomes (1)
Risk factor assessment
To identify risk factors for the development of BOS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study startApr 2015
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Bronchiolitis Obliterans SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Schneiderman, MD, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072849
- Sponsor's protocol ID
- SCT 1214 BOS
- Status last verified
- Nov 2024
- First submitted
- 2 Mar 2017
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chien JW, Martin PJ, Gooley TA, Flowers ME, Heckbert SR, Nichols WG, Clark JG. Airflow obstruction after myeloablative allogeneic hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2003 Jul 15;168(2):208-14. doi: 10.1164/rccm.200212-1468OC. Epub 2003 Mar 20.
PubMed 12649126Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socie G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. doi: 10.1038/sj.bmt.1705637. Epub 2007 Mar 12.
PubMed 17351647Bashoura L, Gupta S, Jain A, Couriel DR, Komanduri KV, Eapen GA, Safdar A, Broglio KR, Adachi R, Dickey BF. Inhaled corticosteroids stabilize constrictive bronchiolitis after hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jan;41(1):63-7. doi: 10.1038/sj.bmt.1705877. Epub 2007 Oct 15.
PubMed 17934530Kaya Z, Weiner DJ, Yilmaz D, Rowan J, Goyal RK. Lung function, pulmonary complications, and mortality after allogeneic blood and marrow transplantation in children. Biol Blood Marrow Transplant. 2009 Jul;15(7):817-26. doi: 10.1016/j.bbmt.2009.03.019.
PubMed 19539213Norman BC, Jacobsohn DA, Williams KM, Au BK, Au MA, Lee SJ, Moravec CK, Chien JW. Fluticasone, azithromycin and montelukast therapy in reducing corticosteroid exposure in bronchiolitis obliterans syndrome after allogeneic hematopoietic SCT: a case series of eight patients. Bone Marrow Transplant. 2011 Oct;46(10):1369-73. doi: 10.1038/bmt.2010.311. Epub 2010 Dec 6.
PubMed 21132024Hildebrandt GC, Fazekas T, Lawitschka A, Bertz H, Greinix H, Halter J, Pavletic SZ, Holler E, Wolff D. Diagnosis and treatment of pulmonary chronic GVHD: report from the consensus conference on clinical practice in chronic GVHD. Bone Marrow Transplant. 2011 Oct;46(10):1283-95. doi: 10.1038/bmt.2011.35. Epub 2011 Mar 28.
PubMed 21441964Pulsipher MA, Skinner R, McDonald GB, Hingorani S, Armenian SH, Cooke KR, Gracia C, Petryk A, Bhatia S, Bunin N, Nieder ML, Dvorak CC, Sung L, Sanders JE, Kurtzberg J, Baker KS. National Cancer Institute, National Heart, Lung and Blood Institute/Pediatric Blood and Marrow Transplantation Consortium First International Consensus Conference on late effects after pediatric hematopoietic cell transplantation: the need for pediatric-specific long-term follow-up guidelines. Biol Blood Marrow Transplant. 2012 Mar;18(3):334-47. doi: 10.1016/j.bbmt.2012.01.003. Epub 2012 Jan 14.
PubMed 22248713Majhail NS, Rizzo JD, Lee SJ, Aljurf M, Atsuta Y, Bonfim C, Burns LJ, Chaudhri N, Davies S, Okamoto S, Seber A, Socie G, Szer J, Van Lint MT, Wingard JR, Tichelli A; Center for International Blood and Marrow Transplant Research; American Society for Blood and Marrow Transplantation; European Group for Blood and Marrow Transplantation; Asia-Pacific Blood and Marrow Transplantation Group; Bone Marrow Transplant Society of Australia and New Zealand; East Mediterranean Blood and Marrow Transplantation Group; Sociedade Brasileira de Transplante de Medula Ossea. Recommended screening and preventive practices for long-term survivors after hematopoietic cell transplantation. Bone Marrow Transplant. 2012 Mar;47(3):337-41. doi: 10.1038/bmt.2012.5.
PubMed 22395764Gassas A, Craig-Barnes H, Dell S, Doyle J, Schechter T, Sung L, Egeler M, Palaniyar N. Chest health surveillance utility in the early detection of bronchiolitis obliterans syndrome in children after allo-SCT. Bone Marrow Transplant. 2013 Jun;48(6):814-8. doi: 10.1038/bmt.2012.228. Epub 2012 Nov 19.
PubMed 23165500Prais D, Sinik MM, Stein J, Mei-Zahav M, Mussaffi H, Steuer G, Hananya S, Krauss A, Yaniv I, Blau H. Effectiveness of long-term routine pulmonary function surveillance following pediatric hematopoietic stem cell transplantation. Pediatr Pulmonol. 2014 Nov;49(11):1124-32. doi: 10.1002/ppul.22944. Epub 2013 Nov 4.
PubMed 24574432Madanat-Harjuoja LM, Valjento S, Vettenranta K, Kajosaari M, Dyba T, Taskinen M. Pulmonary function following allogeneic stem cell transplantation in childhood: a retrospective cohort study of 51 patients. Pediatr Transplant. 2014 Sep;18(6):617-24. doi: 10.1111/petr.12313. Epub 2014 Jul 7.
PubMed 25041660
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03072849
- Acronym / sponsor ID
- SCT 1214 BOS
- Conditions
- Bronchiolitis Obliterans Syndrome
- Keywords
- Pediatrics, Airflow obstruction, Chronic graft-vs-host disease, Bronchiolitis obliterans syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- 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.
This study aims to determine whether or not early spirometric detection and management of obstructive lung disease with combined fluticasone/azithromycin/montelukast therapy (FAM) can attenuate declining lung function, prevent the development of bronchiolitis obliterans, and improve patient outcomes following hematopoietic stem cell transplant.
Detailed description
Bronchiolitis obliterans syndrome (BOS) is an inflammatory condition of the lungs that leads to obstructive physiology, irreversible fibrosis of terminal bronchioles, and obliteration of the small airways. In both children and adults, the prevalence of BOS is approximately 6% in those with chronic graft-vs-host disease (cGVHD), although this may be a gross underestimation given current diagnostic guidelines. Once diagnosed, the prognosis is extremely unfavorable. BOS carries a mortality rate of approximately 40-60%, with a five year survival rate of 13%.
Early on, BOS is symptomatically silent. Once symptoms are present, there is a high likelihood of irreversible disease regardless of the combination of immune suppression used. Given these circumstances, early diagnosis is of utmost importance, and can be characterized by an isolated and subclinical decline in lung function. Recent studies have suggested that early decline in lung function on pulmonary function testing (PFT) may be representative of developing BOS.
Due to the lack of consistent screening and diagnostic criteria, many patients with evolving BOS elude a timely diagnosis, thereby jeopardizing their chance of survival. In response, several experts have recommended frequent PFT screening and a modified, less stringent set of diagnostic criteria with the goal of establishing earlier diagnosis and timely intervention.
Traditionally, treatment of BOS has included aggressive immunosuppression, leaving patients at risk for life-threatening invasive infections, multi-system co-morbidities, and the threat of lung transplantation. Recent studies have demonstrated that early management with agents such as inhaled corticosteroids (ICS), macrolides, and leukotriene receptor antagonists (LTRA) can lead to improvements in both lung function and clinical symptoms.
This study aims to evaluate the utility of frequent and routine pulmonary surveillance in pediatric patients who have undergone allogenic HSCT. Our prospective study design provides a novel framework for the implementation of standardized lung function screening every three months in the first two years following HSCT. With this, we hypothesize that standardized PFT screening will improve diagnostic sensitivity and allow for earlier intervention in patients with evolving airway obstruction and BO.
This study also aims to evaluate the efficacy of inhaled fluticasone, azithromycin, and montelukast (FAM therapy) in the management of early airflow obstruction in pediatric patients following allogenic HSCT. Early airflow obstruction is defined by pulmonary function testing (FEV1 decline of ≥10% predicted with a FVC <0.8). With this, we hypothesize that FAM therapy will attenuate the progression of airflow obstruction and improve lung function in those with irreversible airflow obstruction at one and two years when compared to historical controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Transplant Recipients | – | Procedure: Pulmonary function testing, Drug: FAM TherapyPediatric patients ages 6-18 years who have received allogenic hematopoietic stem cell transplant for any reason. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients undergoing allogenic hematopoietic stem cell transplant
Key inclusion criteria (14 listed)
- Diagnosis: Patients undergoing myeloablative allogenic hematopoietic stem cell transplant for any indication (both malignant and non-malignant) are eligible.
- Graft: Eligible patients will have one or more of the following donor stem cell sources:
- Eligible patients will have one of the following sources of donor stem cells:
- Conditioning Regimen: Patients expecting to receive any type of myeloablative HSCT conditioning regimen are eligible.
- Prior therapies: Patients undergoing stem cell transplant of any kind.
Key exclusion criteria (14 listed)
- Subjects with a previous solid organ transplant.
- Recurrent or progressive malignancy requiring anti-cancer therapy.
- Subjects with evidence of underlying obstructive pulmonary disease prior to transplant (clinical history of asthma or baseline FEV1 <80% predicted with FEV1/FVC <80%).
- Known history of allergy or intolerance to Montelukast, Zafirleukast, Azithromycin, Erythromycin, Clarithromycin, Prednisone, or Sirolimus.
- Chronic supplemental oxygen requirement or hypoxemia <92% SpO2.
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 |
|---|---|---|
| Pulmonary function testingAlso: PFT, Spirometry, Plethysmography, Diffusion capacityEach enrolled patient will receive pulmonary function testing every three months. Pulmonary function testing includes spirometry, plethysmography, and diffusion capacity measurements. | Procedure or surgery | Stem Cell Transplant Recipients |
| FAM TherapyAlso: Fluticasone (Inhaled), Azithromycin, MontelukastAll patients who have evidence of early airflow obstruction on pulmonary function testing will be started on FAM therapy. Early airflow obstruction is defined by a FEV1 decline of ≥10% predicted in addition to a FVC <0.8. | Drug | Stem Cell Transplant Recipients |
Primary outcome
Lung function
Time frame: 2 years
Change in lung function at 12 and 24 months post-HSCT
Survival
Time frame: 2-4 years
Overall survival at 2 years post-HSCT
1 secondary outcome
Risk factor assessment
Time frame: 2 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 19 Nov 2024.
- Background: PubMed 12649126Chien JW, Martin PJ, Gooley TA, Flowers ME, Heckbert SR, Nichols WG, Clark JG. Airflow obstruction after myeloablative allogeneic hematopoietic stem cell transplantation. Am J Respir Crit Care Med. 2003 Jul 15;168(2):208-14. doi: 10.1164/rccm.200212-1468OC. Epub 2003 Mar 20.
- Background: PubMed 17351647Bergeron A, Belle A, Chevret S, Ribaud P, Devergie A, Esperou H, Ades L, Gluckman E, Socie G, Tazi A. Combined inhaled steroids and bronchodilatators in obstructive airway disease after allogeneic stem cell transplantation. Bone Marrow Transplant. 2007 May;39(9):547-53. doi: 10.1038/sj.bmt.1705637. Epub 2007 Mar 12.
- Background: PubMed 17934530Bashoura L, Gupta S, Jain A, Couriel DR, Komanduri KV, Eapen GA, Safdar A, Broglio KR, Adachi R, Dickey BF. Inhaled corticosteroids stabilize constrictive bronchiolitis after hematopoietic stem cell transplantation. Bone Marrow Transplant. 2008 Jan;41(1):63-7. doi: 10.1038/sj.bmt.1705877. Epub 2007 Oct 15.
- Background: PubMed 19539213Kaya Z, Weiner DJ, Yilmaz D, Rowan J, Goyal RK. Lung function, pulmonary complications, and mortality after allogeneic blood and marrow transplantation in children. Biol Blood Marrow Transplant. 2009 Jul;15(7):817-26. doi: 10.1016/j.bbmt.2009.03.019.
- Background: PubMed 21132024Norman BC, Jacobsohn DA, Williams KM, Au BK, Au MA, Lee SJ, Moravec CK, Chien JW. Fluticasone, azithromycin and montelukast therapy in reducing corticosteroid exposure in bronchiolitis obliterans syndrome after allogeneic hematopoietic SCT: a case series of eight patients. Bone Marrow Transplant. 2011 Oct;46(10):1369-73. doi: 10.1038/bmt.2010.311. Epub 2010 Dec 6.
- Background: PubMed 21441964Hildebrandt GC, Fazekas T, Lawitschka A, Bertz H, Greinix H, Halter J, Pavletic SZ, Holler E, Wolff D. Diagnosis and treatment of pulmonary chronic GVHD: report from the consensus conference on clinical practice in chronic GVHD. Bone Marrow Transplant. 2011 Oct;46(10):1283-95. doi: 10.1038/bmt.2011.35. Epub 2011 Mar 28.
- Background: PubMed 22248713Pulsipher MA, Skinner R, McDonald GB, Hingorani S, Armenian SH, Cooke KR, Gracia C, Petryk A, Bhatia S, Bunin N, Nieder ML, Dvorak CC, Sung L, Sanders JE, Kurtzberg J, Baker KS. National Cancer Institute, National Heart, Lung and Blood Institute/Pediatric Blood and Marrow Transplantation Consortium First International Consensus Conference on late effects after pediatric hematopoietic cell transplantation: the need for pediatric-specific long-term follow-up guidelines. Biol Blood Marrow Transplant. 2012 Mar;18(3):334-47. doi: 10.1016/j.bbmt.2012.01.003. Epub 2012 Jan 14.
- Background: PubMed 22395764Majhail NS, Rizzo JD, Lee SJ, Aljurf M, Atsuta Y, Bonfim C, Burns LJ, Chaudhri N, Davies S, Okamoto S, Seber A, Socie G, Szer J, Van Lint MT, Wingard JR, Tichelli A; Center for International Blood and Marrow Transplant Research; American Society for Blood and Marrow Transplantation; European Group for Blood and Marrow Transplantation; Asia-Pacific Blood and Marrow Transplantation Group; Bone Marrow Transplant Society of Australia and New Zealand; East Mediterranean Blood and Marrow Transplantation Group; Sociedade Brasileira de Transplante de Medula Ossea. Recommended screening and preventive practices for long-term survivors after hematopoietic cell transplantation. Bone Marrow Transplant. 2012 Mar;47(3):337-41. doi: 10.1038/bmt.2012.5.
- Background: PubMed 23165500Gassas A, Craig-Barnes H, Dell S, Doyle J, Schechter T, Sung L, Egeler M, Palaniyar N. Chest health surveillance utility in the early detection of bronchiolitis obliterans syndrome in children after allo-SCT. Bone Marrow Transplant. 2013 Jun;48(6):814-8. doi: 10.1038/bmt.2012.228. Epub 2012 Nov 19.
- Background: PubMed 24574432Prais D, Sinik MM, Stein J, Mei-Zahav M, Mussaffi H, Steuer G, Hananya S, Krauss A, Yaniv I, Blau H. Effectiveness of long-term routine pulmonary function surveillance following pediatric hematopoietic stem cell transplantation. Pediatr Pulmonol. 2014 Nov;49(11):1124-32. doi: 10.1002/ppul.22944. Epub 2013 Nov 4.
- Background: PubMed 25041660Madanat-Harjuoja LM, Valjento S, Vettenranta K, Kajosaari M, Dyba T, Taskinen M. Pulmonary function following allogeneic stem cell transplantation in childhood: a retrospective cohort study of 51 patients. Pediatr Transplant. 2014 Sep;18(6):617-24. doi: 10.1111/petr.12313. Epub 2014 Jul 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis Obliterans Syndrome, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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 14 inclusion and 14 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 19 Nov 2024. 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 United States. 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?
Lung function (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT03072849, which also lists 11 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 19 Nov 2024.