Clinical trials: Steroid Refractory Acute Graft Versus Host Disease
Steroid Resistant Acute Graft Versus Host Disease
Early Access Program With Inolimomab in Steroid-refractory Acute Graft Versus Host Disease
Leukotac (inolimomab) is not approved yet for marketing in any region. In the absence of medical options and based on the safety and efficacy data obtained during the clinical development program (in a phase III (INO-107) and in…
- Trial name
- NCT05047328
- Testing
- inolimomab
- Where
- France
- Sponsor
- ElsaLys Biotech
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.
Graft vs Host Disease
Ruxolitinib In GvHD
The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD. In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute GvHD in…
- Trial name
- RIG (NCT02396628)
- Testing
- Experimental intervention, Standard treatment
- Where
- 11 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Prof. Dr. Nikolas von Bubnoff
Graft Versus Host Disease
In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus
In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine
- Trial name
- T-REG (NCT01453140)
- Testing
- Cyclophosphamide and Sirolimus, Low dose IL-2 with Cytoxan + Sirolimus, Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Hackensack Meridian Health
Steroid Refractory GVHD
ECP Combination Study
Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects.
- Trial name
- NCT05052385
- Testing
- Ruxolitinib, Extracorporeal photopheresis, Ibrutinib
- Where
- 38 sites in Belgium, Denmark and 12 more
- Volunteers
- 319 people
- Sponsor
- European Society for Blood and Marrow Transplantation
Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
- Trial name
- NCT06321198
- Testing
- iMSC
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Anhui Provincial Hospital
Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease
Efficacy and Safety of FMT Capsule Treating Steroid-refractory GI-aGvHD
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids.
- Trial name
- NCT04622475
- Testing
- Fecal Microbiota Transplant (FMT) Capsule
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Graft Versus Host Disease
High-Dose Cyclophosphamide for Steroid Refractory GVHD
RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute graft-versus-host disease that did not respond to steroid therapy.
- Trial name
- NCT00492921
- Testing
- Cyclophosphamide
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Acute Graft-versus-Host Disease
Universal CNK-UT Therapy for Refractory aGVHD
This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric…
- Trial name
- CNK-UT (NCT06750133)
- Testing
- Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)
- Where
- 2 sites in China
- Volunteers
- 23 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
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
Acute Graft-Versus-Host Disease
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.
- Trial name
- NCT04971551
- Testing
- Jaktinib Hydrochloride Tablets
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
GVHD - Graft-Versus-Host Disease
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial to compare the efficacy and safety of remestemcel-L-rknd (remestemcel-L), ex-vivo cultured adult human mesenchymal stromal cells (MSC)…
- Trial name
- NCT07568535
- Testing
- Remestemcel-L-rknd
- Volunteers
- 180 people
- Sponsor
- Mesoblast, Ltd.
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
Graft-versus-host Disease (GVHD)
A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1)
The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
- Trial name
- NCT02953678
- Testing
- Ruxolitinib, Prednisone or methylprednisolone
- Where
- 38 sites in United States
- Volunteers
- 71 people
- Sponsor
- Incyte Corporation
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
Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD
Graft versus host disease is a serious and often life-threatening complication in allogeneic haematopoietic stem cell transplantation.
- Trial name
- NCT02824653
- Testing
- Mesenchymal Stem Cells
- Where
- Pakistan
- Volunteers
- 10 people
- Sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
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 Acute Graft-versus-host Disease
Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit…
- Trial name
- IDUNN (NCT04629833)
- Testing
- MC0518, BAT
- Where
- 42 sites in France, Germany and 3 more
- Volunteers
- 210 people
- Sponsor
- medac GmbH
Ulcerative Colitis
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
The purpose of this study is to identify whether an Accelerated or Intensified Infliximab induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an open label multi-centre randomised controlled…
- Trial name
- PREDICT UC (NCT02770040)
- Testing
- Infliximab
- Where
- Australia
- Volunteers
- 138 people
- Sponsor
- Austin Health
Steroid Refractory GVHD, Graft Vs Host Disease
Itacitinib and Tocilizumab for Steroid Refractory Acute Graft Versus Host Disease
The study's primary objective is designed to assess the safety and tolerability, and determine the maximum tolerated dose (MTD) of both itacitinib and tocilizumab when given in combination to patients with steroid-refractory…
- Trial name
- GVHD (NCT04070781)
- Testing
- Itacitinib, Tocilizumab
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Columbia University