Clinical trials: Gvhd
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
Dermatitis, Contact, Dermatitis
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters
The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.
- Conditions
- Dermatitis, Contact, Dermatitis, Dermatitis, Chronic, Dermatitis, Eczematous
- Trial name
- NCT07056569
- Testing
- 047_TD Dermatitis cream twice a day for 28 days
- Where
- 3 sites in Italy
- Volunteers
- 90 people
- Sponsor
- Biokosmes Srl
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
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
Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD…
- Trial name
- NCT05567406
- Testing
- Belumosudil
- Sponsor
- Kadmon, a Sanofi Company
Graft Versus Host Disease, GVHD
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids
- Conditions
- Graft Versus Host Disease, GVHD, Acute-graft-versus-host Disease, Acute GVHD
- Trial name
- NCT05263999
- Testing
- Itolizumab
- Where
- 118 sites in United States, Australia and 10 more
- Volunteers
- 158 people
- Sponsor
- Equillium
Grade B aGVHD, Grade C aGVHD
A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD)
The study plans to treat at least 60 pediatric participants, male and female, between the ages of 2 months and 17 years inclusive with aGVHD following allogeneic hematopoietic stem cell transplant (HSCT) that has failed to…
- Conditions
- Grade B aGVHD, Grade C aGVHD, Grade D aGVHD
- Trial name
- NCT02336230
- Testing
- remestemcel-L
- Where
- 20 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mesoblast, Inc.
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
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
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
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
- Trial name
- EiFFEL (NCT04289103)
- Testing
- Inolimomab (Leukotac)
- Volunteers
- 65 people
- Sponsor
- ElsaLys Biotech
Graft-versus-host Disease, Acute-graft-versus-host Disease
An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)
This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.
- Trial name
- NCT03339297
- Testing
- Defibrotide, Standard of Care
- Where
- 62 sites in United States, Austria and 12 more
- Volunteers
- 152 people
- Sponsor
- Jazz Pharmaceuticals
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
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
Steroid Refractory Graft Versus Host Disease
CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
- Trial name
- NCT07576699
- Testing
- CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
- Volunteers
- 12 people
- Sponsor
- Cellenkos, Inc.
Atopic Keratoconjunctivitis
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC.
- Trial name
- NCT07395232
- Testing
- DFL24498, Vehicle, dexamethasone sodium phosphate (DSP) ophthalmic solution
- Where
- 19 sites in United States, Italy and 1 more
- Volunteers
- 153 people
- Sponsor
- Dompé Farmaceutici S.p.A
SCID
JSP191 Antibody Targeting Conditioning in SCID Patients
A Phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as JSP191, in patients with Severe Combined Immune Deficiency undergoing blood stem cell transplantation
- Trial name
- NCT02963064
- Testing
- Humanized anti-CD117 Monoclonal Antibody (JSP191)
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Jasper Therapeutics, Inc.
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.
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
Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant…
- Conditions
- Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease, Grade D Acute Graft Versus Host Disease
- Trial name
- NCT02652130
- Testing
- Remestemcel-L
- Where
- 20 sites in United States
- Volunteers
- 32 people
- Sponsor
- Mesoblast, Inc.