Clinical trials: Steroid Refractory GVHD
Graft-versus-host Disease (GVHD)
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
- Trial name
- NCT03112603
- Testing
- Ruxolitinib, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX)
- Where
- 191 sites in United States, Australia and 29 more
- Volunteers
- 330 people
- Sponsor
- Incyte Corporation
Steroid-Refractory Acute Graft Versus Host Disease
T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)
The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).
- Trial name
- 1802 (NCT04128319)
- Testing
- T-Guard
- Where
- 24 sites in United States
- Volunteers
- 3 people
- Sponsor
- Xenikos
Chronic Graft-versus-host-disease
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial…
- Trial name
- NCT04189432
- Testing
- SCM-CGH
- Where
- 11 sites in South Korea
- Volunteers
- 84 people
- Sponsor
- SCM Lifescience Co., LTD.
GVHD,Acute
Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD)
The objective of this clinical study is to demonstrate safety and feasibility of single-dose infusion of Ossium MSCs product (OSSM-001) to treat steroid refractory acute GVHD (SR-aGVHD).
- Trial name
- NCT05443464
- Testing
- OSSM-001
- Sponsor
- Ossium Health, Inc.
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as…
- Trial name
- ARES (NCT04769895)
- Testing
- MaaT013
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 66 people
- Sponsor
- MaaT Pharma
Graft Versus Host Disease
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Chronic Graft Versus Host Disease
The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.
- Trial name
- NCT02195869
- Testing
- Ibrutinib
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Pharmacyclics LLC.
Steroid Refractory Acute Graft Versus Host Disease
Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen) Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems (ECP) in pediatric participants with steroid-refractory…
- Trial name
- NCT02524847
- Testing
- Methoxsalen, Extracorporeal Photopheresis (ECP)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 29 people
- Sponsor
- Therakos, Inc., a Mallinckrodt Company
Steroid-refractory Acute Graft-versus-host Disease
Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
The purpose of this trial is the comparative evaluation of overall response rate (ORR) in paediatric participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Visit Day 28 after treatment with MC0518 or…
- Trial name
- BALDER (NCT06075706)
- Testing
- MC0518, BAT
- Where
- 36 sites in France, Germany and 3 more
- Volunteers
- 49 people
- Sponsor
- medac GmbH
Acute Graft Versus Host Disease
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while…
- Trial name
- NCT00032773
- Testing
- pentostatin for injection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Graft Versus Host Disease
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
The purpose of this study is to evaluate the efficacy and gather additional safety information for Prochymal® in participants who have failed to respond to steroid treatment of Grades B-D acute GVHD.
- Trial name
- NCT00366145
- Testing
- Prochymal®, Standard of Care for GVHD
- Where
- 70 sites in United States, Australia and 4 more
- Volunteers
- 260 people
- Sponsor
- Mesoblast, Inc.
Acute Graft Versus Host Disease
Study of Pharmacokinetics, Activity and Safety of Ruxolitinib in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease
The study was an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days…
- Trial name
- NCT03491215
- Testing
- Ruxolitinib
- Where
- 19 sites in Belgium, Canada and 6 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Allogeneic Hematopoietic Stem Cell Transplantation
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal…
- Trial name
- NCT02993783
- Testing
- Vedolizumab
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 17 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Acute GvHD
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further…
- Trial name
- ALD518-010 (NCT01530256)
- Testing
- ALD518
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Steroid-Refractory Acute Graft Versus Host Disease
A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host…
- Trial name
- 2002 (NCT04934670)
- Testing
- T-Guard, Ruxolitinib
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 12 people
- Sponsor
- Xenikos
Graft-versus-host Disease (GVHD)
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)
The 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…
- Trial name
- NCT06615050
- Testing
- Tacrolimus (Tac), Methotrexate (MTX), Ruxolitinib (Rux)
- Where
- 30 sites in United States
- Volunteers
- 572 people
- Sponsor
- Incyte Corporation
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF)
Managed Access Programs for INC424, Ruxolitinib
The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib
- Conditions
- Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Thrombocythemia Myelofibrosis (PET-MF), Severe/Very Severe COVID-19 Illness
- Trial name
- NCT04745637
- Testing
- Ruxolitinib
- Sponsor
- Novartis Pharmaceuticals
GVHD
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
- Trial name
- NCT05415410
- Testing
- Apraglutide
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 31 people
- Sponsor
- VectivBio AG
Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation
A Study Evaluating the Efficacy and Safety of Neihulizumab vs "Conventional Treatment" to Treat Sr-aGvHD
This study is to assess the efficacy of Neihulizumab versus "conventional therapy" and to evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute Graft-vs-Host Disease
- Trial name
- NCT02694770
- Testing
- Neihulizumab Treatment, Conventional Treatment
- Where
- 2 sites in United States
- Sponsor
- AbGenomics B.V Taiwan Branch
Corticosteroid Refractory Acute Graft vs Host Disease
Safety and Efficacy of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.
- Trial name
- REACH2 (NCT02913261)
- Testing
- Ruxolitinib (RUX), Best Available Therapy (BAT)
- Where
- 103 sites in Australia, Austria and 20 more
- Volunteers
- 310 people
- Sponsor
- Novartis Pharmaceuticals
Steroid Refractory GVHD
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute…
- Trial name
- AURORA (NCT06343792)
- Testing
- RLS-0071
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- ReAlta Life Sciences, Inc.