A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
NCT06585774 · Chronic Graft-versus-host-disease
RecruitingThis study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
PhasePhase 3
TypeInterventional
Age12 Years
WhereBirmingham, Alabama, United States + 121 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multi-Center Clean Air Randomized Controlled Trial in COPD
RecruitingThis is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.
PhasePhase 3
TypeInterventional
Age40 Years
WhereBirmingham, Alabama, United States + 10 more
SponsorJHSPH Center for Clinical Trials
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
RecruitingLPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.
PhasePhase 4
TypeInterventional
Age40 Years – 85 Years
WhereBirmingham, Alabama, United States + 60 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease
NCT05919511 · cGVHD
RecruitingThe purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 31 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Axatilimab for Sclerotic Chronic Graft-versus-Host Disease
NCT07011810 · Chronic Graft Versus Host Disease
RecruitingThis phase II trial tests how well axatilimab works in treating patients with thickening or hardening (sclerosis) of the skin related to chronic graft-versus-host disease after a donor stem cell transplant. Chronic graft-versus-host disease (cGVHD) remains a major complication of donor stem cell transplants. Sclerosis, while not associated with a higher risk of death, can lead to serious disabilities. Usual treatments for cGVHD can be associated with significant side effects and unsatisfactory outcomes. A monoclonal antibody, like axatilimab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Axatilimab blocks a receptor and depletes cells that may be involved in the development of inflammation and fibrosis in cGVHD. Giving axatilimab may improve or prevent worsening of sclerosis related to cGVHD in patients after a donor stem cell transplant.
PhasePhase 2
TypeInterventional
Age18 Years
WhereTampa, Florida, United States + 2 more
SponsorFred Hutchinson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
RecruitingParallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.
PhaseNA
TypeInterventional
Age30 Years
WhereBirmingham, Alabama, United States + 26 more
SponsorTemple University
▾Tap for detailsClick for full details — eligibility, all locations, contacts BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)
NCT05922761 · Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans, Lung Diseases
RecruitingThe 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). The name of the study drugs involved in this study are: * Belumosudil (an immunotherapy) * Fluticasone (an intranasal corticosteroid) * Azithromycin (an antibiotic) * Montelukast (a leukotriene receptor antagonist) * Prednisone (a corticosteroid)
PhasePhase 2
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 4 more
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
NCT04431479 · Chronic Graft Versus Host Disease
RecruitingThis trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.
Phase—
TypeObservational
Age18 Years
WhereGainesville, Florida, United States + 9 more
SponsorFred Hutchinson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
NCT06615050 · Graft-versus-host Disease (GVHD)
RecruitingThe purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation
PhasePhase 3
TypeInterventional
Age18 Years
WherePalo Alto, California, United States + 29 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Boston Early-Onset Chronic Obstructive Pulmonary Disease (COPD) Study
RecruitingChronic obstructive pulmonary disease (COPD) is often caused by cigarette smoking, but genetic predisposition also influences COPD susceptibility. The purpose of this study is to identify genetic factors that predispose some individuals to develop COPD.
Phase—
TypeObservational
AgeAny
WhereBoston, Massachusetts, United States
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
NCT06891755 ·
COPD, Emphysema
RecruitingThe objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
PhaseNA
TypeInterventional
Age40 Years – 84 Years
WhereBirmingham, Alabama, United States + 21 more
SponsorApreo Health, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
NCT05996627 · Chronic Graft Versus Host Disease
RecruitingThis phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 4 more
SponsorFred Hutchinson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts The investigators propose a home hospital model of care that substitutes for treatment in an acute care hospital. Limited studies of the home hospital model have demonstrated that a sizeable proportion of acute care can be delivered in the home with equal quality and safety, reduced cost, and improved patient experience.
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorBrigham and Women's Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain
NCT05701982 ·
COPD, Chronic Musculoskeletal Pain
RecruitingPersons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R\&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.
PhaseNA
TypeInterventional
Age40 Years – 100 Years
WhereBoston, Massachusetts, United States
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)
NCT06462365 · Hematologic Malignancy, GvHD, GVHD,Acute
RecruitingThe purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 4 more
SponsorTr1X, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema
NCT06035120 · Emphysema, Pulmonary,
Emphysema or COPD RecruitingThis is a prospective, open-label, multi-center, single-arm study planned to enroll 200 subjects with heterogeneous emphysema and collateral ventilation (CV) in the target lobe. Subjects will undergo instillation of AeriSeal Foam in the target lobe and subsequent assessment of CV status using Chartis Pulmonary Assessment System. Subjects with CV- status will then undergo placement of Zephyr Valve in the target lobe for bronchoscopic lung volume reduction (BLVR) and be followed for 24 months.
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WherePhoenix, Arizona, United States + 35 more
SponsorPulmonx Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
NCT05236062 · Graft Vs Host Disease, Acute-graft-versus-host Disease, Chronic Graft-versus-host-disease
RecruitingThis study is about determining if an aerobic and resistance exercise intervention is feasible in patients diagnosed with acute or chronic GVHD (Graft-Versus-Host Disease) after having an allogeneic stem cell transplant. The names of the study interventions involved in this study are: * Aerobic and resistance exercise (A+R) - Home-based aerobic and resistance exercise program * Attention control (AC) - Home-based stretching program
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 1 more
SponsorDana-Farber Cancer Institute
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
NCT06619561 · Chronic Graft-Versus-Host Disease (cGVHD)
RecruitingThe purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 25 more
SponsorDeciphera Pharmaceuticals, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
NCT07119229 ·
Emphysema or COPD, Emphysema,
COPD RecruitingA study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
PhaseNA
TypeInterventional
Age22 Years
WhereSan Francisco, California, United States + 2 more
SponsorPulmair Medical, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Inter-lobar Fissure Completion in Patients With Failed Bronchoscopic Lung Volume Reduction
RecruitingThe purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the potential role of lung fissure completion with pleural adhesiolysis strategy (experimental intervention) in severe emphysema/COPD patients with failed bronchoscopic lung volume reduction (BLVR) via the use of endobronchial valves (EBVs) therapy. In select patients, the lung fissure completion with adhesiolysis strategy will be performed by video-assisted thoracoscopic surgery (VATS) guided stapling along the lung fissures to reduce collateral ventilation with adhesions removal and determine whether this experimental strategy will improve outcomes after failed BLVR in patients with severe emphysema/COPD.
PhaseNA
TypeInterventional
Age40 Years – 75 Years
WhereBoston, Massachusetts, United States
SponsorBeth Israel Deaconess Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts