View clinical trials related to Graft vs Host Disease.
Filter by:This randomized pilot clinical trial studies Lactobacillus rhamnosus GG in reducing incidence of graft-versus-host disease in patients who have undergone donor stem cell transplant. Lactobacillus rhamnosus GG may be effective at preventing for graft-versus-host disease caused by a donor stem cell transplant.
Ocular Graft Versus Host Disease (OGVHD) is a serious potential complication of allogeneic bone marrow transplants. The usual treatment is topical cyclosporine but when the treatment is initiated the damage to the lacrimal glands has already taken place. The present study aims to prevent OGVHD in reduced-intensity allogeneic hematopoietic transplants by using topical cyclosporine immediately after the engraftment has been achieved
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma.
Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell transplant, and radiographic evidence of mucosal inflammation will be correlated with the subsequent development of acute graft versus host disease. The primary endpoint is the feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period, as defined by the risk of contrast-related nephropathy or allergic reaction.
In consideration of the fact that the vascular endothelium has been shown to be a target of GvHD in early stage and that the count of CEC may represent a marker of endothelial damage, we want to evaluate the changes in CEC counts of patients affected by hematological disorders undergoing allo-HSCT, as a function of endothelial damage. We will enroll 50 patients affected by hematologic disorders undergoing allo-HSCT. Peripheral blood will be drawn before (T1, baseline) and at the end of the conditioning regimen (T2, pre-transplant), upon confirmation of hematopoietic recovery (T3, engraftment) and thereafter at onset of GVHD (GVHD T4) and one week after the start of steroid therapy (T5, post-GvHD). All patients will also be checked for CEC at day + 28. CEC enumeration will be performed by using the CellSearch® System and a flowcytometry procedure. Through the conduct of this study, we expect to confirm our preliminary results on a larger series of patients, and to evaluate the predictive role of CEC on the occurrence of GvHD and prognostic response to treatment of GvHD. The possibility of early identification of patients who do not respond to traditional treatments of GvHD, and for this reason at a higher risk of morbidity and mortality, may allow greater individualization of the therapeutic program, for example with the introduction as early as possible of alternative treatments. In addition, the identification of patients at higher risk of non-responsiveness to steroid treatment, would allow, through a closer monitoring, the early introduction of additional treatment before the development of resistance/refractoriness to treatment of GvHD. The present study takes the form of a prospective study. The primary endpoint is the identification and enumeration of CECs in peripheral blood of patients with hematological disorder undergoing allo-HSCT, as a function of endothelial damage. The secondary endpoint is to define the prognostic and predictive value of the changes of CEC counts on the diagnosis of GvHD and response to treatment.
- To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures. - To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
In this study, a combination of two antibodies both conjugated to a cell-killing toxin (so-called immunotoxins) will be evaluated. The antibodies are directed against T-cell antigens 'cluster of differentiation 3 antigen' (CD3) and CD7. Previous in vitro studies have demonstrated that this particular immunotoxin-combination, named T-Guard, acts synergistically in eliminating T cells with a preference for killing activated T-cells. In a subsequent clinical pilot-study, T-Guard has generated encouraging results when applied as third-line therapy for patients suffering form steroid-resistant acute Graft-versus-Host Disease (GVHD). Extensive biological and clinical responses could be noted in the absence of severe acute toxicities. Building on these results, the current study aims at evaluating the safety and efficacy of T-Guard for treating steroid-resistant GVHD when administered in an earlier phase of the disease process, i.e. as second-line instead of as third-line therapy.
The purpose of this study is to determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy.
The participant is invited to take part in this study because they have chronic Graft versus Host Disease (cGVHD) that is not responding to standard treatment with steroids. This research study is a way of gaining new knowledge about the treatment of patients with cGVHD. This research study is evaluating a drug called abatacept. Abatacept is a drug that alters and suppresses the immune system. Abatacept is approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe active rheumatoid arthritis in adults and of severe juvenile idiopathic arthritis (JIA) in patients who have failed prior therapy with disease-modifying anti-rheumatic drugs (DMARDs). These are autoimmune conditions, ie caused by an overactive immune system that attacks normal tissues and organs. It is currently being tested in a variety of other autoimmune conditions. In this case it is considered experimental. cGVHD is caused by the donor cells attacking various organs of the recipient. The investigators try to minimize this immune attack by using corticosteroids such as prednisone. In severe cases prednisone is not sufficient and other immunosuppressive medications are used in addition in order to more efficiently control cGVHD and to limit the dose and consequently the multiple side-effects of corticosteroids. This study is being done to determine if the use of abatacept is safe in patients with cGVHD and if it can facilitate a better control of cGVHD. During this study the participants will be evaluated for side effects from the treatment with abatacept, and for response of the cGVHD to the treatment. There will be two groups of participants in the study. The first group will be treated at a relatively low dose of abatacept. If this is found to be safe then the second group will be treated at a higher dose. Three to four tablespoons of blood will be drawn at every 2 week visit in order to determine your blood counts, kidney and liver function. Some of the blood will be used in a research lab in order to study measures of your immune system and how they might be affected by the treatment.
The objective of this study is to determine the maximum tolerated dose (MTD) of bortezomib in combination with calcineurin inhibitor and methotrexate as acute graft versus host disease (aGVHD) prophylaxis in pediatric patients undergoing allogeniec hematopoietic stem cell transplant (alloHSCT)