This trial is evaluating whether RGI-2001 will improve 5 secondary outcomes in patients with Graft Versus Host Disease (cGvHD). Measurement will happen over the course of Day 180 post-transplant.
This trial requires 49 total participants across 1 different treatment group
This trial involves a single treatment. RGI-2001 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"Our patients with GVHD received only a single dose of dexamethasone; this treatment resulted in complete resolution of all symptoms for 16 of 22 patients. The clinical utility of this modality merits confirmation in larger prospective study. If further study confirms these promising preliminary results, patients with GVHD and multiple organ failure may have a chance for improved outcomes if treated with dexamethasone." - Anonymous Online Contributor
"About 25.8 million transplant patients and 20.4 million non-transplant patients are at risk of acquiring transplant-related GVHD. This makes up 13.2% and 23.2% of all living adults, respectively.\n" - Anonymous Online Contributor
"Symptoms of GvHD may include skin rashes, mouth sores, flu-like symptoms, diarrhea, sore eyes, hair loss, swollen lymph nodes and swollen tonsils. The clinical course of GvHD is very variable. Some patients have only mild symptoms and those with serious GvHD will recover, but in many cases GvHD is permanent and has a significant impact on the quality of life. There are numerous diagnostic and scoring systems available to help guide clinicians with the diagnosis and treatment of GvHD. However, none currently incorporate the clinical features of this disorder. Therefore, it is not always possible to predict the course of GvHD in any given individual." - Anonymous Online Contributor
"Graft vs host disease in transplants is not universal as demonstrated by the presence of GVHD in transplants but not in host-matched transplants. GVHD in transplants is more likely to result from Graft vs GVH transplantation or from a combination of both causes." - Anonymous Online Contributor
"It is unclear why patients with BMT who are genetically susceptible will develop this condition. It appears to be due to the body's own mechanisms rather than environmental triggers. GvHD can occur from a donor's cells in the graft." - Anonymous Online Contributor
"Both conventional chemotherapy and alemtuzumab have been found to be effective in alleviating GVHD symptoms. Other medications used to treat GVHD include methotrexate, mercaptopurine, tacrolimus, etanercept, and ibuprofen. Steroids also play a part in the treatment of GVHD. Treatments are effective not only because they can alleviate side effects, but also to prevent GVHD because it appears to have the opposite effect.\n\nGraft vs host disease affects 1 to 2 percent of all adult transplants. Approximately 95 percent of patients develop GVHD symptoms." - Anonymous Online Contributor
"rgi-1981 (anti-alphav integrin) represents a novel human endogenous retroviral envelope glycoprotein of ~43KD. As with the alpha-fusobacterial env glycoproteins, rgi-1981 may serve as an envelope glycoprotein for virion attachment to a specific cell type. Although rgi-0181 has not yet been functionally investigated, the fact that the gag gene has been disrupted in this retroviral genome may mean that a functional envelope, albeit not associated with any infectivity factor, is required for trans-packaging of the genome into the mature virion." - Anonymous Online Contributor
"Rgi-2001 can be a safe, highly-targeted agent for the induction and enhancement of tumor-specific T-cell responses, while concurrently preventing graft vs. host disease in vivo. This combination of properties can provide a potential novel therapeutic strategy to combat GVHD-associated cancers, and in future studies, combining Rgi-2001 with other immunomodulatory agents or strategies may further increase the potential of these immunotherapies for the treatment of acute and chronic disease states." - Anonymous Online Contributor
"G-2 is a promising candidate for the treatment of patients with GvHD. However, in this study of 36 patients, no fatalities were anticipated. The study also showed that G-2 reduces the likelihood of myelosuppression and the severity of the symptoms. More studies of patients after G+96 treatment are needed." - Anonymous Online Contributor
"It has been very hard to treat and to prevent GvHD with donor T-cells. Recent approaches are being evaluated, however there are not many treatment options, and donor T-cells are still the best that can be used. It is essential to get transplants in order to keep patients healthy, but to start treatment for patients, it is still to be determined which treatments are effective. There are some things on the table that will help patients. When evaluating, the patient’s age, GvHD phenotype, clinical stage, treatment intent, graft type, donor type, and gender will be taken into consideration." - Anonymous Online Contributor
"The current investigation did not find support for the hypothesis that the aetiology of GVHD was primary to the aetiology of the GVHD. This suggests that the primary aetiological factors leading to GVHD occur during the early part of the infection and not after immunity has developed against specific microbes, and may be an important prognostic indicator" - Anonymous Online Contributor
"This preliminary study supports the use of Rgi-2001 and indicates that this treatment may be a useful adjunct therapy for improving quality of life in those with GvHD. Further research is indicated on longer-term use, side-effects and efficacy of this treatment." - Anonymous Online Contributor