Clinical trials: Chronic Graft Versus Host Disease
Chronic Graft Versus Host Disease
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
- Trial name
- NCT07135973
- Testing
- Belumosudil
- Volunteers
- 26 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
Improving Outcomes Assessment in Chronic GVHD
The purpose of this study is to see if recent guidelines proposed by the National Institutes of Health for the diagnosis, staging, and response assessment of people with chronic GVHD can improve our understanding of this…
- Trial name
- NCT00637689
- Where
- 9 sites in United States
- Volunteers
- 601 people
- Sponsor
- Fred Hutchinson Cancer Center
Chronic Graft vs. Host Disease
Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
Background: Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT).
- Trial name
- NCT00092235
- Where
- United States
- Volunteers
- 650 people
- Sponsor
- National Cancer Institute (NCI)
GVHD (Acute or Chronic)
A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children
This study is a single arm, open label Phase Ib clinical trial, consisting of two parts: the first part is a safety introduction trial, and the second part is a dose escalation trial.
- Trial name
- GVHD (NCT07350057)
- Testing
- 1mg /kg VIC-1911
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID)
Evaluation of Patients With Immune Function Abnormalities
This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation.
- Conditions
- Chronic Granulomatous Disease (CGD), X-Linked Severe Combined Immune Deficiency (XSCID), Leukocyte Adhesion Deficiency 1 (LAD), Graft Versus Host Disease (cGvHD)
- Trial name
- NCT00128973
- Where
- United States
- Volunteers
- 3,500 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Granulomatous Disease
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
Background: CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used.
- Trial name
- NCT03910452
- Testing
- Busulfan, Alemtuzumab, Cyclophosphamide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Graft Versus Host Disease
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically…
- Trial name
- ROCKnrol-1 (NCT06143891)
- Testing
- Belumosudil, Prednisone, Prednisolone
- Where
- 151 sites in United States, Argentina and 22 more
- Volunteers
- 260 people
- Sponsor
- Sanofi
Chronic Graft-versus-host-disease
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
- Trial name
- NCT06388564
- Testing
- Axatilimab, Ruxolitinib, Corticosteroids
- Where
- 68 sites in United States, Belgium and 5 more
- Volunteers
- 130 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
This 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).
- Trial name
- AXemplify-357 (NCT06585774)
- Testing
- INCA034176, Corticosteroids
- Where
- 131 sites in United States, Australia and 11 more
- Volunteers
- 240 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT07124078
- Testing
- INCA034176, Best available Treatment (BAT)
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).
- Trial name
- NCT06263478
- Testing
- INCA034176
- Where
- 16 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Incyte Biosciences Japan GK
Chronic Graft Versus Host Disease
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to <18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for…
- Trial name
- schoolROCK (NCT07116031)
- Testing
- Belumosudil
- Where
- 35 sites in United States, Belgium and 11 more
- Volunteers
- 37 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use…
- Trial name
- NCT07771439
- Testing
- Belumosudil, Best available therapy (BAT)
- Volunteers
- 356 people
- Sponsor
- Sanofi
Post-COVID-19 Condition, Ulcerative Colitis
Emerging Indications for Hyperbaric Oxygen Treatment
This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric…
- Conditions
- Post-COVID-19 Condition, Ulcerative Colitis, Crohn Disease, Calciphylaxis
- Trial name
- NCT07240649
- Testing
- Hyperbaric oxygen treatment (HBOT), 100% Oxygen
- Volunteers
- 100 people
- Sponsor
- Jay C. Buckey Jr.
Chronic Graft Versus Host Disease in Eye
Observational Cohort Study on Ocular Chronic Graft-Versus-Host Disease
This study is a multicenter, prospective, observational cohort study designed to enroll a total of 340 patients undergoing allogeneic hematopoietic stem cell transplantation.
- Trial name
- NCT07794800
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Ruijin Hospital
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT06821542
- Testing
- INCA034176, Best Available Therapy (BAT)
- Where
- 130 sites in Austria, Belgium and 14 more
- Volunteers
- 9 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.
- Trial name
- NCT06843408
- Testing
- INCA034176
- Where
- 9 sites in China
- Volunteers
- 32 people
- Sponsor
- Incyte Corporation
Non-sclerotic Cutaneous Chronic Graft-versus-host Disease
Study of the Safety and Efficacy of Ruxolitinib Cream for Non-Sclerotic Chronic Cutaneous Graft-Versus-Host Disease
The purpose of this study is to compare the safety and effects of ruxolitinib 1.5% cream with those of standard moisturizers in people with non-sclerotic chronic cutaneous GVHD.
- Trial name
- NCT03954236
- Testing
- topical ruxolitinib 1.5% cream, Topical vehicle/moisturizer cream
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Chronic Graft Vs. Host Disease
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
- Trial name
- NCT05544032
- Testing
- axatilimab
- Sponsor
- Incyte Corporation
Chronic Graft Versus Host Disease, cGVHD
Axatilimab in Combination With Extracorporeal Photopheresis (ECP) in Chronic Graft-versus-Host Disease
The purpose of this study is to see whether giving participants a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is effective against chronic Graft-versus-Host Disease (cGVHD).
- Trial name
- NCT06663722
- Testing
- Axatilimab, Extracorporeal Photopheresis
- Where
- 3 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of Miami