Clinical trials: Steroid Refractory
Chronic Graft Versus Host Disease
Ruxolitinib Plus Fostamatinib for Steroid Refractory cGvHD
This is an open-label phase I study of fostamatinib in combination with ruxolitinib for the treatment of chronic GvHD with a suboptimal response to corticosteroids.
- Trial name
- NCT06233110
- Testing
- Fostamatinib, Ruxolitinib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Stefanie Sarantopoulos, MD, PhD.
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.
Immune Thrombocytopenic Purpura (ITP)
Association of FcγRIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients
Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by antibody-mediated platelet destruction. The complex pathogenesis of ITP with multiple challenges to immune system in terms of genetic…
- Trial name
- NCT02877212
- Testing
- Eltrombopag
- Where
- Pakistan
- Volunteers
- 75 people
- Sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
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
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
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
Ulcerative Colitis
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
- Trial name
- NCT00279435
- Testing
- visilizumab
- Where
- 39 sites in United States, Australia and 13 more
- Volunteers
- 25 people
- Sponsor
- Facet Biotech
GVHD, Acute Stem Cell Transplant Complications
MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib
The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT).
- Trial name
- NCT06075225
- Testing
- Ruxolitinib
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Sichuan University
Chronic Graft vs Host Disease
Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease
A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib
- Trial name
- GVHD-TReG (NCT03683498)
- Testing
- Regulatory T-cell enriched infusion
- Where
- Spain
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Graft Versus Host Disease, Allogeneic Hematopoietic Cell Transplant Recipient
Phase 1 Infused Donor T Regulatory Cells in Steroid Dependent/Refractory Chronic GVHD
Chronic graft versus host disease (cGVHD) is a common complication of bone marrow or hematopoietic cell transplant from another person (allogeneic transplant).
- Trial name
- NCT01911039
- Testing
- Regulatory T Cells
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Laura Johnston
Chronic Graft Versus Host Disease
Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease
This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with…
- Trial name
- NCT03007238
- Testing
- Aldesleukin, Extracorporeal Photopheresis, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- City of Hope Medical Center
Neurological Autoimmune Diseases
IA or PE - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases
In this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with IA or PE in patients with neurological autoimmune diseases.
- Trial name
- NCT04687332
- Testing
- Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- University Medical Center Mainz
Intestinal GVHD, Steroid Refractory GVHD
Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013
The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.
- Trial name
- ORION (NCT05017688)
- Testing
- Blood and stool sample collection
- Where
- 9 sites in France
- Volunteers
- 40 people
- Sponsor
- MaaT Pharma
Graft vs. Host Disease
Brentuximab Vedotin for Steroid Refractory GvHD
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies.
- Trial name
- NCT01596218
- Testing
- Brentuximab Vedotin
- Where
- 5 sites in United States
- Volunteers
- 35 people
- Sponsor
- Massachusetts General Hospital
Steroid-refractory Diamond-Blackfan Anemia (DBA)
Study of the Selective GlyT1 Inhibitor Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia
Background: Diamond-Blackfan anemia (DBA) is an inherited disease that affects the bone marrow. People with DBA have chronic anemia that can be severe. Many must have frequent transfusions of red blood cells.
- Trial name
- NCT05828108
- Testing
- Bitopertin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Graft vs Host Disease, Alogenic Hematopoietic Transplant
Rituximab for GVHD
This is a prospective, open-label pilot study in which 4 doses of Rituximab are administered to patients who have developed SR-aGVHD following allogeneic hematopoietic transplant (AHT).
- Trial name
- Rituximab GVHD (NCT00578591)
- Testing
- Rituximab
- Where
- 2 sites in United States
- Sponsor
- Baylor College of Medicine
Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)
A Study of LBP-MARCO and Ruxolitinib in People With Graft-Versus-Host Disease (GVHD)
The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease…
- Trial name
- NCT07913672
- Testing
- Ruxolitinib, LBP- MARCO
- Where
- 7 sites in United States
- Volunteers
- 16 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Eustachian Tube Dysfunction, Endolymphatic Hydrops
Refractory Eustachian Tube Dysfunction: Are the Symptoms Related to Endolymphatic Hydrops
The purpose of this study is to evaluate the benefit of treatment of refractory Eustachian tube dysfunction with standard treatment for endolymphatic hydrops.
- Trial name
- NCT01661777
- Testing
- Nasal steroid, Myringotomy tube placement, Diuretic
- Where
- United States
- Sponsor
- Vanderbilt University
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