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Graft Versus Host Disease clinical trials

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NCT ID: NCT01616056 Completed - Clinical trials for Graft Versus Host Disease

Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

Start date: June 2012
Phase: Phase 2
Study type: Interventional

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.

NCT ID: NCT01596075 Recruiting - Clinical trials for Graft Versus Host Disease

Safety and Efficacy of Cannabidiol for Grade I/II Acute Graft Versus Host Disease (GVHD) After Allogeneic Stem Cell Transplantation

Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic stem cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplants from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed. The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects. As such, it may be effective for both prevention and treatment of acute GVHD after allogeneic stem cell transplantation.

NCT ID: NCT01549665 Recruiting - Clinical trials for Graft-Versus-Host Disease

Umbilical Cord Blood-derived Mesenchymal Stem Cells for the Treatment of Steroid-refractory Acute or Chronic Graft-versus-host-disease

GVHD-MSC
Start date: January 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Graft-versus-host-disease (GVHD) is a major complication following allogeneic hematopoietic stem cell transplantation (allo-HSCT) which may cause acute life-threatening morbidity or chronic disabilities. Although corticosteroid, the primary agent to treat GVHD, may be effective for some patients, outcomes of those who are refractory to corticosteroid are dismal. Secondary agents can be used for steroid-refractory cases; however, their efficacy is variable and usually limited. The quality of life issue of chronic GVHD is especially important for pediatric survivors who have longer life expectancy than adults. Many in-vitro and in-vivo data support immunoregulatory properties of mesenchymal stem cells(MSCs)and possibilities of treating diseases caused by immune dysregulation such as GVHD. Recent data revealed that bone marrow-derived MSCs were very useful to treat steroid-refractory acute GVHD, which led to improved overall survival compared with controls. More recently, a number of reports suggest MSCs may also be useful in treating chronic GVHD as well as acute GVHD. It has been also reported that third party MSCs are also useful as well as those from autologous or HLA-matched donors. The investigator recently demonstrated that MSCs obtained from umbilical cord blood (UCB) have similar immunosuppressive properties as bone marrow-MSCs. UCB-MSCs can be obtained without doing any harm to donors that it may be more appropriate source of MSCs than bone marrow for off-the-shelf use. However, little is known about the safety and efficacy of UCB-MSCs in treating GVHD. Therefore, the investigator designed this study to evaluate the safety and efficacy of UCB-MSCs in treating pediatric patients with steroid-refractory acute or chronic GVHD.

NCT ID: NCT01522716 Terminated - Clinical trials for Graft-Versus-Host Disease

Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.

NCT ID: NCT01487577 Active, not recruiting - Clinical trials for Graft Versus Host Disease

Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention

Start date: June 2010
Phase: Phase 2
Study type: Interventional

Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia, lymphoma, and other childhood cancers that were once considered incurable. A major barrier to the application of this life-saving treatment is acute graft-versus-host disease (GVHD) which develops in approximately 30-80% of patients and is a leading cause of death from transplant complications. Current GVHD prevention methods are not very efficacious and lead to unacceptable side effects. Mycophenolate mofetil (MMF), an anti-rejection medication used in solid organ transplants, has shown great promise in BMT recipients. The effectiveness of MMF depends on blood levels of mycophenolic acid (MPA, the active form of MMF). Different patients have been found to have different blood levels of MPA when they are given the same dose of MMF. The purpose of this study is to study a novel method of giving MMF based on its metabolism (pharmacokinetics) to achieve desired blood levels of MPA for prevention of GVHD. Non-invasive ways of monitoring the drug exposure will also be studied. The ultimate goal of this study is to improve approaches to GVHD prevention and improve outcomes of BMT in children.

NCT ID: NCT01485055 Terminated - Clinical trials for Graft Versus Host Disease

Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Start date: December 2011
Phase: Phase 2
Study type: Interventional

Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant. Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment. The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD. Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.

NCT ID: NCT01460914 Active, not recruiting - Clinical trials for Graft Versus Host Disease

Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment

Start date: October 2011
Phase:
Study type: Observational

Extracorporeal Photopheresis (ECP) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with UV light. ECP is currently a standard therapy for cutaneous T-cell lymphoma (CTCL) and is also effective for graft-versus-host disease (GVHD). The investigators would like to study the outcomes (response rates) of patients receiving ECP treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.

NCT ID: NCT01453140 Terminated - Clinical trials for Graft Versus Host Disease

In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

T-REG
Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine

NCT ID: NCT01428973 Active, not recruiting - Clinical trials for Hematological Malignancies

Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The present project is a multicenter phase II trail aiming at comparing which of the two postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent graft-versus-host disease (GVDH). The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity conditioning with Fludarabine/total body irradiation (TBI) or Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free survival due to a lower incidence of relapse/progression.

NCT ID: NCT01385124 Recruiting - Clinical trials for Graft Versus Host Disease

Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation

Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Graft versus host disease (GVHD) is one of the major causes of death in patients undergoing allogeneic hematopoietic cell transplantation. Despite prophylactic measures, the incidence of acute GVHD is estimated at 40-60% among patients receiving transplant from HLA-identical sibling donors, and may even reach 75% in patients receiving HLA-matched unrelated transplants. More effective prevention and treatment strategies are needed. The immunomodulatory and anti-inflammatory properties of Cannabinoids have been shown in animal models of various inflammatory diseases including multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis. Cannabidiol is a major non-psychoactive cannabinoid, which has potent anti-inflammatory and immunosuppressive effects. As such, it may reduce the incidence and severity of GVHD after allogeneic stem cell transplantation.