EQ001 for Graft vs Host Disease
This study is evaluating whether a drug may help treat a common complication of stem cell transplantation.
See full descriptionAbout the trial for Graft vs Host Disease
Treatment Groups
This trial involves 3 different treatments. EQ001 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether EQ001 will improve 2 primary outcomes and 10 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Study Day 85.
Patient Q & A Section
Does eq001 improve quality of life for those with graft vs host disease?
Results from a recent paper suggest the EQ001 may have a role in the clinical management of the GVHD-affected patient. However, the results need to be carefully interpreted given the limited number of people in the study, its lack of power and significance and its short duration.
How many people get graft vs host disease a year in the United States?
Graft vs host disease occurs in about one person out of 4,000 transplants. The disease has a higher incidence in female recipients but in male recipients it occurs with a similar frequency to men of the same age.
What is graft vs host disease?
This retrospective review suggests that BMT recipients were more likely than controls to develop BV, BV-related disease, or death. This supports the growing evidence that BMT does indeed induce an immune reaction toward the BMT, a phenomenon known as GVHD. However, this association may be spurious. A careful follow-up study with a large number of subjects is needed before a conclusion can be reached.
What are common treatments for graft vs host disease?
Graft vs Host Disease is most often treated with corticosteroids. It has been found to be effective and effective and safe. It is critical that patients are monitored closely to make sure no relapse occurs. The best results can be obtained if these treatment options are carefully managed.
What causes graft vs host disease?
Although the exact mechanisms are still largely unknown, it appears to be an immune-related response. The cause may be related to graft vs host disease. As there is no known cure, therapies may be needed. Treatment such as corticosteroids, anti-lymphocyte globulin, anti-lymphocyte immunosuppressants, T-cell depletion therapy, and antithymocyte globulin may be tried. Graft vs host disease is a major cause of death in patients after organ transplant.
What are the signs of graft vs host disease?
Many common symptoms of GVHD are nonspecific and nonfatal. Patients with persistent symptoms, such as diarrhea, can have a poor prognosis, especially in more advanced patients. Although most symptoms are nonspecific, one cannot rule out a graft vs host disease diagnosis solely on clinical findings, so a biopsy of the graft-versus-host-tissue is the definitive test.
Can graft vs host disease be cured?
GvHD cannot be prevented or cured by standard immunosuppressive protocols, although complete and permanent remission can be obtained in the vast majority of patients with acute GvHD. T-cell depletion treatment may increase the chance of cure. Chronic GvHD is more difficult to overcome since autologous hematopoietic stem cell transplantation is often required.
Is eq001 safe for people?
Treatment with anti-TNF may result in a prolonged reduction in lymphocytes and natural killer cells, which increases the risk of infection. Equations for individuals with severe disease or a history of malignancy (including those with a history of a serious or life-threatening infection) may cause an increase in infection. Equations for individuals with a history of lymphoproliferative/hematopoietic diseases or active autoimmune disease may increase the risk of autoimmune disease. The risks of the treatment must be weighed against the potential benefits in an individualised setting.
What are the common side effects of eq001?
In clinical experiments, systemic pharmacokinetics are generally comparable with pharmacokinetics of the investigational compound in healthy subjects. In contrast, local pharmacokinetics are significantly different from those in healthy subjects. However, all patients tolerated the medication well. Systemic and localized tolerability may be optimized in clinical trials or observational studies.
Is eq001 typically used in combination with any other treatments?
A variety of combinations of different treatments were used. The most common combination of treatments used as a part of the standard conditioning regimen is the combination (c) of Eq001 with alemtuzumab and a single dose of fludarabine, (Eq)(A). This was performed in patients who have completed a myeloablative conditioning regimen and therefore had no residual disease. The most common reason for the use of Eq001 in combination with Eq(A) was due to a shortage of Eq001 in the conditioning and, more importantly, due to the higher-risk conditioning regimen.
What is eq001?
Based on the unique role of NK cells in GVHD and HSC transplantation, it is anticipated that IL-21 will have the greatest therapeutic potential in inducing transplant tolerance. Clinical trials could help us to evaluate its effect in GVHD and HSC transplantation.
Who should consider clinical trials for graft vs host disease?
Clinical trial availability and a desire for a new treatments option represent a positive incentive in patients with GVHD. We believe a larger effort from the pharmaceutical industry would result in more clinical trials in GVHD. Since it is more common for patients in the US, we believe a more comprehensive and open minded attitude towards clinical trials by both patients and physicians is required.