Clinical trials: Steroid Refractory Acute Graft Versus Host Disease
- Condition Steroid Refractory Acute Graft Versus Host Disease
- Funder type Industry (pharma, biotech, devices)
Fecal Microbiota Transplantation
Treatment of Steroid Refractory Gastro-intestinal Acute GVHD afteR AllogeneiC HSCT With fEcal Microbiota tranSfer
Patients who have a gastrointestinal acute Graft versus host disease (GVHD) received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality.
- Trial name
- HERACLES (NCT03359980)
- Testing
- fecal microbiota transfer
- Where
- 16 sites in France, Italy and 1 more
- Volunteers
- 24 people
- Sponsor
- MaaT Pharma
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
Steroid-refractory Acute Graft-versus-Host Disease, Treatment-refractory Acute Graft-versus-Host Disease
Neihulizumab (ALTB-168) in Patients With Steroid-refractory Acute Graft-versus-host Disease or Treatment-refractory Acute Graft-versus-host Disease
A Phase I study to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD)
- Trial name
- NCT03327857
- Testing
- Neihulizumab (ALTB-168)
- Where
- 13 sites in United States
- Volunteers
- 37 people
- Sponsor
- AltruBio Inc.
Acute-graft-versus-host Disease
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction.
- Trial name
- NCT04883918
- Testing
- ASC930
- Volunteers
- 60 people
- Sponsor
- ASC Therapeutics
Steroid-refractory Acute Graft-versus-host Disease
A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment
It is a phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of VUM02 Injection in patients with acute graft-versus-host disease (aGvHD) who have failed systemic steroid therapy.
- Trial name
- ESTEVS-I/II (NCT06677255)
- Testing
- VUM02 Injection (UC-MSCs)+BAT, The control group with Best Available Therapy (BAT)
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Wuhan Optics Valley Vcanbiopharma Co., Ltd.
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
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.
Steroid-refractory Acute Graft Versus Host Disease
Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
The purpose of this study is to assess the efficacy and safety of ruxolitinib therapy in Chinese adults and adolescents (≥ 12 years old) with Grade II-IV steroid-refractory acute graft versus host disease (SR-aGvHD).
- Trial name
- NCT06462469
- Testing
- Ruxolitinib
- Where
- 9 sites in China
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Graft-versus-host Disease (GVHD)
An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored…
- Trial name
- NCT03147742
- Testing
- Ruxolitinib
- Where
- 33 sites in United States
- Sponsor
- Incyte Corporation
Graft Vs Host Disease
ALPN-101 in Steroid-resistant or Steroid-refractory Acute GVHD
The Balance study will assess the safety, tolerability, and efficacy of an investigational drug called ALPN-101 in adults with steroid-resistant or steroid-refractory acute graft versus host disease (aGVHD).
- Trial name
- Balance (NCT04227938)
- Testing
- ALPN-101
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Alpine Immune Sciences, Inc.
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
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
Graft vs Host Disease
Safety and Efficacy Study of T-Guard to Treat Steroid-resistant Acute GVHD
In this study, a combination of two antibodies both conjugated to a cell-killing toxin (so-called immunotoxins) will be evaluated.
- Trial name
- NCT02027805
- Testing
- T-Guard
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 20 people
- Sponsor
- Xenikos
Acute Graft Versus Host Disease
A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant
This study is to establish the safety, determine if there is an improvement in steroid refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine the changes of aGvHD-associated T-cell clones in…
- Trial name
- NCT02436460
- Testing
- AbGn-168H
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- AbGenomics B.V Taiwan Branch
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.
Graft-versus-host Disease (GVHD)
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
To provide ruxolitinib through an expanded access to treat a single patient with cGVHD
- Trial name
- NCT05722912
- Testing
- Ruxolitinib
- Sponsor
- Incyte Corporation
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.
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
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.
Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly…
- Conditions
- Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease, Graft-versus-host-disease, Graft Vs Host Disease
- Trial name
- NCT03172455
- Testing
- Glassia
- Sponsor
- Impatients N.V. trading as myTomorrows