[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchiolitis-obliterans-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchiolitis-obliterans-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100510155","phase-2-belumosudil-for-bronchiolitis-obliterans-preventiontherapy-bebop-100510155",false,"NCT05922761","BElumosudil for Bronchiolitis Obliterans Prevention\u002FTherapy (BEBOP)","An Open-Label, Phase 2 Study to Evaluate the Activity of Belumosudil in Subjects With New Onset and Incipient Bronchiolitis Obliterans Syndrome Following Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria Cohort A:\n\n* Diagnosis of BOS after HCT using pulmonary function testing, per the NIH diagnostic criteria17 OR the Atypical BOS criteria33 3.1.2.1 NIH Diagnostic Criteria for BOS. All of the following must be met:\n\n  * FEV1\u002FVC \\\u003C 0.7 or \\\u003C5th percentile of predicted (FEV1 = Forced Expiratory Volume in 1 second; VC = Vital Capacity (either FVC, Forced Vital Capacity, or SVC, Slow Vital Capacity, whichever is greater)\n  * FEV1 \\\u003C75% of predicted with ≥ 10% absolute decline over less than 2 years. FEV1 should not correct to \\>75% of predicted with albuterol, and the absolute decline for the corrected values should still remain ≥ 10% over 2 years.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage).\n  * One of the two supporting features of BOS:\n\n    * i - Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT OR\n    * ii - Evidence of air trapping by PFTs: RV (Residual Volume) \\> 120% of predicted or RV\u002FTLC elevated outside the 90% confidence interval (RV\u002FTotal Lung Capacity).\n* Atypical Criteria for BOS:\n\n  * FEV1 \\\u003C80% of predicted with ≥ 10% absolute decline over the last 2 years or since transplant. The remote comparator can be an evaluation of PFTs done within 2 years of the PFTs assessment being evaluated to determine eligibility or the PFT assessment done prior to transplant.\n  * VC \\\u003C 80% of predicted.\n  * FEV1\u002FVC \\> 0.7.\n  * Absence of active infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs or computed tomographic scans or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, bronchoalveolar lavage) or active non-infectious lung disease (such as interstitial lung disease) that explain spirometric changes or chest CT findings.\n\nInclusion Criteria for Cohort B:\n\n-Diagnosis of BOS-0p\n\n* Decline in FEV1 of 10% - 19% of predicted compared with pretransplant testing OR\n* Decline in predicted FEF25-75% (Forced Expiratory Flow between 25% and 75% of vital capacity) \\> 25%\n\nInclusion Criteria for Cohorts A and B:\n\n* Age ≥18 years. Belumosudil is currently being tested in pediatric populations and the safety and efficacy in pediatric patients have not yet been established. A protocol amendment to include pediatric patients will be considered once safety in pediatric patients is established.\n* ECOG performance status ≤2 (Karnofsky ≥ 60%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * WBC ≥ 3,000\u002FμL\n  * Absolute neutrophil count ≥ 1,500\u002F μL\n  * Platelets ≥ 50,000\u002FmcL\n  * AST(SGOT)\u002FALT(SGPT) ≤ 5 × institutional ULN\n* No evidence of relapsed malignancy at the time of enrollment. Formal re-staging is not required for trial entry.\n* All females of childbearing potential must have a negative serum or urine pregnancy test \\\u003C 7 days before study drug administration.\n* The ability to understand and willingness to sign a written consent document.\n\nExclusion Criteria for Cohorts A and B:\n\n* Participants who have received prior therapy specifically for BOS. Therapy for cGVHD in the absence of BOS is permissible.\n* Prior exposure to belumosudil.\n* Participants who are receiving any other investigational immunosuppressive agents for cGVHD.\n* Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persistent fever without signs or symptoms will not be interpreted as an active uncontrolled infection.\n* Known human immunodeficiency virus infection. Interactions between belumosudil and anti-retroviral agents have not been established.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).\n\nThe name of the study drugs involved in this study are:\n\n* Belumosudil (an immunotherapy)\n* Fluticasone (an intranasal corticosteroid)\n* Azithromycin (an antibiotic)\n* Montelukast (a leukotriene receptor antagonist)\n* Prednisone (a corticosteroid)",[26,27,28,29],"Bronchiolitis Obliterans Syndrome","Bronchiolitis Obliterans","Lung Diseases","Chronic Graft Versus Host Disease",[26,27,31,32,33,29],"Lung Disease","Allogeneic hematopoietic stem cell transplant","HSCT","RECRUITING","2026-06-08",{"date":37,"type":38},"2026-06-10","ACTUAL",{"date":40,"type":38},"2024-05-31",{"date":42,"type":20},"2027-12-31",{"name":44,"class":45},"Dana-Farber Cancer Institute","OTHER",6,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100517532","phase-2-lam-001-in-lung-transplant-recipients-with-bronchiolitis-obliterans-syndrome-100517532","NCT06018766","LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.","A Randomized, Placebo-controlled Phase 2 Study to Demonstrate the Safety and Efficacy of the Addition of LAM-001 to Standard Immunosuppression Therapy for Chronic Lung Allograft Dysfunction (BOS).","INSPO-BOS","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Recipient of a double pulmonary allograft at least 12 months before study entry\n* Subjects with clinically diagnosed CLAD-BOS phenotype (all 3 required)\n\n  * BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.\n  * Diagnosis within 12 months of screening visit.\n  * FEV1 decline is persistent as defined by decline sustained for \\> 30 days.\n* Currently receiving Standard Immunosuppression. This is defined as a combination of 3 medications including Prednisone, Mycophenolate or Azathioprine, and Tacrolimus or Cyclosporine. The dosing should be stable for 4 weeks prior to screening.\n* Absence of oral sirolimus or everolimus treatment for at least 4 weeks prior to screening based on the half-life and resolution of the tissue effects\n* Stable enough to enable routine post-transplant bronchoscopy with BAL and biopsy when indicated\n* Capable of understanding the purposes and risks of the study\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry\n* Women of childbearing potential if sexually active must agree to using highly effective contraception during study and for 90 days after discontinuation of study treatment\n* Women of childbearing potential must refrain from breast feeding or donating eggs for the duration of the study and for 90 days after the last dose of study treatment\n* Male participants must agree to use a condom during sexual contact with a female of childbearing potential while participating in the study and for 90 days following discontinuation of investigational product use\n* Male participants must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Patients with re-transplantation or currently listed for re-transplantation\n* Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.\n* Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable donor-specific antibodies (DSA) levels at the Screening Visit are eligible for the study\n* Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the investigator are eligible.\n* Mechanical ventilation within 12 weeks prior to the randomization\n* Patient has baseline resting oxygen saturation of \\\u003C 89% on room air or use of supplemental oxygen at rest at screening\n* Evidence of functional airway stenosis (i.e., bronchomalacia\u002F tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and\u002For Baseline Visit\n* Known hypersensitivity to sirolimus or everolimus\n* Currently enrolled in another investigational trial for obstructive chronic lung allograft dysfunction (BOS)\n* Patients with chronic renal failure, defined as serum creatinine \\> 2.5 mg\u002FdL at screening, or requiring chronic dialysis\n* Patients with liver disease and serum bilirubin \\> 3-fold upper limit of normal range or transaminases \\> 2.5 upper limit of normal range\n* Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, except for treated, localized basal and squamous cell carcinomas\n* Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized skin cancer.\n* History of severe allergic reaction to lactose (patients with lactose intolerance are eligible)\n* Patients with uncontrolled hypertension",{"count":56,"type":20},30,[23],"The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation.\n\nThe main questions it aims to answer are:\n\n* Is LAM-001 safe in these patients?\n* Is LAM-001 effective in slowing BOS progression?\n\nParticipants will:\n\n* Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks\n* Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period\n* Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination\n* Submit weekly home spirometry monitoring\n\nResearchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.",[26,60,61],"Chronic Lung Allograft Dysfunction","Lung Transplantation",[26,60,63,64,65,66],"Lung Transplant Rejection","Sirolimus","mTOR inhibitor","CLAD","2026-05-13",{"date":69,"type":38},"2026-05-18",{"date":71,"type":38},"2023-08-17",{"date":73,"type":20},"2026-12",{"name":75,"class":45},"Steven Hays, MD",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":17,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":76},"100392539","novel-pulmonary-function-measures-for-diagnosis-of-bronchiolitis-obliterans-syndrome-following-hematopoietic-stem-cell-transplantation-in-children-100392539","NCT04391335","Novel Pulmonary Function Measures for Diagnosis of Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem-Cell Transplantation in Children","Inclusion Criteria:\n\n* Male and female participants aged 6 -17.9 years old.\n* Received HSCT treatment at least 6 months prior to enrollment in study.\n* Participants should have an FEV1%pred value greater than 40%.\n* Participant understands the study procedures and is willing to participate in the study as indicated by signature on the informed consent or assent.\n* Participant must be able to perform a breath hold for 16s.\n* Participant meets MRI screening criteria\n\nExclusion Criteria:\n\n* Participant has had a cold or respiratory infection in the last four weeks.\n* Participant requires supplemental oxygen or has a daytime room air oxygen saturation ≤ 95%.\n* Participant is unable to perform spirometry or plethysmography maneuvers.\n* Participant is pregnant or lactating.","6 Years",{"count":85,"type":20},15,"OBSERVATIONAL","In this study, we will study 129Xe-MRI and LCI as tools for diagnosis of BOS in pediatric patients who have received Hematopoietic Stem Cell Transplantation (HSCT) and have been identified as eligible for this study. Participants will be required to have vital signs collected, complete breathing tests and complete an MRI. The MRI will require participants to perform breath holds in the MRI scanner with xenon gas while being coached by a research assistant.",[26],[90,91,92],"Stem cell transplantation","Xenon MRI","Lung","2026-02-26",{"date":95,"type":38},"2026-02-27",{"date":97,"type":38},"2020-10-20",{"date":99,"type":20},"2026-06-30",{"name":101,"class":45},"The Hospital for Sick Children"]