CLINICAL TRIAL

T-Guard for Graft vs Host Disease

Grade III
Refractory
Recruiting · 18+ · All Sexes · Maastricht, Netherlands

This study is evaluating whether a new drug called T-Guard might be more effective than ruxolitinib in treating people with steroid-refractory acute graft-versus-host disease.

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About the trial for Graft vs Host Disease

Eligible Conditions
Steroid Refractory Acute Graft Versus Host Disease · Graft vs Host Disease

Treatment Groups

This trial involves 2 different treatments. T-Guard 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 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
T-Guard
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Ruxolitinib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
or total cumulative dose of 60 mg If someone takes more than 60 mg of methylprednisolone in 3 days or less, they are likely to experience new organ involvement. show original
There was no improvement after seven days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day. show original
Patients who began treatment with methylprednisolone (or equivalent) and had improvement in skin GVHD but not visceral GVHD after seven days were given a greater than or equal to 2mg/kg/day dose. show original
After myeloid engraftment is confirmed, patients may receive growth factor supplementation. show original
The patient or someone else who is not involved in their care (in case the patient is not capable of providing verbal consent but capable of signing the ICF) should have given written consent. show original
Patients who have skin GVHD and develop visceral aGVHD during treatment with methylprednisolone (or equivalent) of greater than or equal to 1mg/kg/day and do not improve after 3 days of greater than or equal to 2mg/kg/day are considered to have organ improvement or progression. show original
In order to provide consent for treatment, the patient must be at least 18 years old. show original
Patients who have undergone an allo-HSCT from any donor source or graft source are eligible show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Days 6, 14, 28, and 56
Screening: ~3 weeks
Treatment: Varies
Reporting: Days 6, 14, 28, and 56
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Days 6, 14, 28, and 56.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether T-Guard will improve 1 primary outcome and 12 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Day 28.

Duration of Complete Response (DoCR)
DAY 28
DoCR will be evaluated only in the set of participants who are in CR at Day 28 post-randomization. The primary definition of DoCR is the time from Day 28 until an aGVHD target organ worsens by at least 1 stage and requires a significant escalation in treatment, or death.
DAY 28
Complete Response (CR)
DAY 28
The primary objective of this trial is to assess the rate of CR on Day 28 post-randomization in Grades III and IV SR-aGVHD patients treated with T-Guard treatment in comparison to ruxolitinib.
DAY 28
Incidence of Toxicities
DAY 56
The frequency of Grade 3-5 toxicities per CTCAE version 5 occurring after randomization will be tabulated by organ system for each treatment arm. The maximum severity of reported toxicities during that period will also be summarized.
DAY 56
Incidence of Infections
DAY 90
The frequency of Grade 2-3 infections occurring after randomization will be tabulated by infection site, date of onset, and severity. The cumulative incidence of Grade 2-3 infections will be described by treatment arm.
DAY 90
Relapse/Progression of Underlying Malignancy
DAY 180
The time from randomization until malignancy relapse/progression will be described for each treatment arm, with death prior to relapse/progression treated as a competing risk.
DAY 180
Relapse-free Survival (RFS)
DAY 180
RFS is defined as being alive and free of malignancy relapse/progression. The time from randomization until malignancy relapse/progression or death will be described for each arm.
DAY 180
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can graft vs host disease be cured?

Although treatment with immunosuppressive regimens can prevent or minimize the need for BMT, acute GVHD remains a significant complication that may prove fatal in most patients. There is an urgent clinical need for therapies that minimize GVHD while preserving BMT availability for GVHD prophylaxis and/or therapy.

Anonymous Patient Answer

What is graft vs host disease?

GvHD is a common and often severe manifestation of post-thymus transplant infection. GvHD, which typically strikes children 3 to 6 weeks after transplant with a high incidence over time, is a clinical entity that affects both immunologic and immunosuppressive therapy. It is often triggered by an antigen-presenting cell (APC) triggering T-cell activation. In contrast, the immunosuppressive drugs used to prevent GvHD have been shown to alter the number and functions of GVHD APCs. Understanding the APC and T-cell activation is therefore important to understand any future drug development for GvHD and is the focus of much current research.

Anonymous Patient Answer

What are the signs of graft vs host disease?

The signs and symptoms of GvHD frequently overlap with acute graft rejection, but they are not exactly the same. Symptoms vary according to the organ being affected. GvHD symptoms can be classified as systemic or localised symptoms.\n

Anonymous Patient Answer

What are common treatments for graft vs host disease?

Treatment is highly individualised based on the characteristics of both the graft donor and the recipient. These include the underlying condition of each patient, their physical abilities and their preferences. The mainstay of treatment is supportive treatment including measures to reduce the severity of symptoms. Potential transplant-related immunosuppressive drugs, such as azathioprine or mycophenolate mofetil, are used to prevent organ rejection after the transplant..

Anonymous Patient Answer

How many people get graft vs host disease a year in the United States?

This article presents how many people have graft vs host disease and what conditions may be associated with an increased risk of developing this condition.

Anonymous Patient Answer

What causes graft vs host disease?

GvHD affects > 10,000 patients annually in the U.S. alone. In most patients, it is of the B cell or T cell-dependent, and therefore graft specific. In other cases, it is not graft directed. The immune system's T cell-mediated response is critical, because it enables the immune system to discriminate between host and foreign materials. Immune system abnormalities are the most important variables in determining what type of GVHD develops.

Anonymous Patient Answer

Has t-guard proven to be more effective than a placebo?

T-guard significantly reduced the occurrence and severity of acute graft-versus-host disease when compared with a placebo. In addition, T-guard significantly increased the probability of grafting-versus-host disease resolution. ClinicalTrials.gov number: NCT00505845.

Anonymous Patient Answer

Is t-guard typically used in combination with any other treatments?

Despite their use in the past, the T-guard has low compliance in clinical circumstances. In recent years, many new indications were developed to extend the indications for T-guard, which showed a positive impact on the use of the device. However, no single new indication has changed the use of T-guard in patients with hematopoietic stem cell transplantation.

Anonymous Patient Answer

Have there been any new discoveries for treating graft vs host disease?

There has been no breakthrough discovery for treating GvHD. Despite this, there have been some recent advances and some hope for future treatments.\n...this chapter contains an update of treatments for GvHD and recommendations for when to start treatment. There are several treatments in the pipeline that are being tested such as [bortezomib, donor specific transfusions, and rituximab]. None of these therapies have been proven to be effective. Many more projects are being done for GvHD. It is likely that many treatments will be [developed], but the lack of progress to date suggests that more research may be needed before improvements in treatment can be achieved.

Anonymous Patient Answer

How does t-guard work?

T-guard does not provide any clinical benefit when used during the first post-transplant week. However, in patients who receive a heart transplant from grafts who have not received t-GVHD prophylactic treatment, T-guard may significantly reduce the risk of developing t-GVHD, particularly acute t-GVHD. This is particularly important given that tnT-pro-B cytokines are thought to be important mediators of the development of t-GVHD in graft recipients without a matching donor, and because an earlier start of T-cell immunosuppression post transplant may also decrease the risk of development of t-GVHD.

Anonymous Patient Answer

Have there been other clinical trials involving t-guard?

T-Guard is a form of skin graft made up of a blend of silicone and liquid silicone. The silicone, unlike most other silicone-based products, is non-allergic. T-Guard is routinely used in skin transplantation today both in USA and in Europe, although it is still technically a “semisolid silicone” product (i.e., it contains some liquids), and therefore has not been allowed in all countries as a “medical grade silicone”.

Anonymous Patient Answer

What is the primary cause of graft vs host disease?

Graft vs host disease has many causes. A significant share of these causes can be controlled by the GVHD prevention measures for the transplanted organ. To prevent and control these causes, clinicians should be aware of the relevant measures.

Anonymous Patient Answer
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