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Graft vs Host Disease clinical trials

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NCT ID: NCT04886726 Recruiting - Clinical trials for Graft Versus Host Disease

PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

Start date: December 23, 2021
Phase: Phase 1
Study type: Interventional

So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival

NCT ID: NCT04883918 Not yet recruiting - Clinical trials for Acute-graft-versus-host Disease

ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

Start date: December 2023
Phase: Phase 2
Study type: Interventional

Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT. Placenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.

NCT ID: NCT04859946 Active, not recruiting - Clinical trials for Hematologic and Lymphocytic Disorder

Itacitinib for the Prevention of Graft Versus Host Disease

Start date: January 11, 2022
Phase: Phase 1
Study type: Interventional

This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.

NCT ID: NCT04852692 Terminated - Clinical trials for Chronic Graft vs Host Disease

A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants

Start date: June 21, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health [NIH] response defined complete response [CR] and partial response [PR]) at Week 24.

NCT ID: NCT04838704 Recruiting - Clinical trials for Graft Versus Host Disease

Ruxolitinib With Calcineurin and Methotrexate vs. Calcineurin Plus Methotrexate and Mycophenolate Mofetil as Graft Versus Host Disease Prophylaxis for HLA-haploidentical Hematopoietic Stem Cell Transplantation

Start date: April 8, 2021
Phase: Phase 4
Study type: Interventional

Low Dose Ruxolitinib with Calcineurin and Methotrexate vs. Calcineurin plus Methotrexate and Mycophenolate mofetil as Graft Versus Host Disease prophylaxis for HLA-haploidentical hematopoietic stem cell transplantation in low-dose antithymocyte globulin (ATG) system.

NCT ID: NCT04792580 Recruiting - Clinical trials for Graft-versus-host-disease

The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease

Start date: October 22, 2022
Phase: Early Phase 1
Study type: Interventional

The objective of this study is to evaluate the clinical efficacy of 5% lifitegrast ophthalmic solution in subjects with dry eye disease secondary to ocular Graft-versus-Host Disease compared to placebo.

NCT ID: NCT04769895 Recruiting - Clinical trials for Steroid Refractory GVHD

MaaT013 as Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients

ARES
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

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 salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

NCT ID: NCT04769648 Active, not recruiting - Clinical trials for Ocular Graft-versus-host Disease

Safety and Efficacy of Pro-ocularâ„¢ 1% in Daily Scleral Lens Wearing Patients With Ocular Graft-versus-Host Disease

Start date: April 15, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical study seeks to evaluate the safety and efficacy of Pro-ocularâ„¢1% topical gel in patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This vehicle-controlled trial will evaluate the investigational drug's effect on signs and symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and serviceable scleral lens wear.

NCT ID: NCT04768907 Available - Clinical trials for Steroid Refractory GVHD

Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease

ATLAS
Start date: n/a
Phase:
Study type: Expanded Access

MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned. In the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.

NCT ID: NCT04752397 Completed - Clinical trials for Graft Vs Host Disease

The Influence of Extracorporeal Photopheresis on Skin Sclerosis

Start date: February 12, 2021
Phase:
Study type: Observational

Extracorporeal photopheresis (ECP), also known as extracorporeal photoimmunotherapy or photochemotherapy, is a leukapheresis-based therapy that has been in clinical use for over three decades after receiving FDA approval in 1988. Extracorporeal photopheresis was initially used for the treatment of T-cell lymphoma. Since its introduction, indications for initiating ECP were continuously extended to the treatment of Graft-versus-Host Disease (GvHD), systemic sclerosis, and in the field of solid organ transplantation. There is also evidence supporting the use of ECP in generalized morphea, a form of scleroderma limited to the skin, and in eosinophilic fasciitis, which is a rare, localized fibrosing disorder of the fascia. Concluding the results of the published studies, there is evidence that ECP has a positive effect on fibrosing disorders of the skin. Furthermore, in clinical practice, it has been observed that patients with systemic sclerosis, who undergo ECP treatment, show improvement of the skin lesions or a deceleration in the formation progress of such lesions during the therapy. Same findings can be observed in patients with sclerotic skin lesions of the skin, for example in the context of a GvHD. There are no clinical studies so far that describe these processes using objective measuring methods. Furthermore, the mechanism of action of ECP in systemic sclerosis and other fibrosing disorders with skin manifestations, has not yet been conclusively clarified. Serological markers for monitoring the progress of the therapy and determining the prognosis are also missing. Thus, a consensus regarding the frequency and duration of ECP for the therapy of systemic scleroderma or sclerotic diseases has not yet been reached. This study aims at evaluating the influence of Extracorporeal Photopheresis on the quality and functionality of sclerotic skin lesions assessed by several objective methods. Furthermore, potential biomarkers, which are being investigated in current studies, are to be determined in order to evaluate the influence of ECP on those biomarkers and better understand the mechanism of action of ECP on systemic sclerosis and fibrosing disorders involving the skin.