CLINICAL TRIAL

Belumosudil (KD025) for Graft vs Host Disease

Recruiting · Any Age · All Sexes · Birmingham, AL

This study is evaluating whether a drug may help treat chronic graft versus host disease.

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About the trial for Graft vs Host Disease

Eligible Conditions
Graft vs Host Disease · Chronic Graft-versus-host-disease

Treatment Groups

This trial involves 2 different treatments. Belumosudil (KD025) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Belumosudil (KD025)
DRUG
Experimental Group 2
Belumosudil (KD025)
DRUG

Eligibility

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Receiving glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
Have persistent cGVHD manifestations and systemic therapy is indicated
Karnofsky Performance Score of ≥ 60 (if aged 16 years or older); Lansky Performance Score of ≥ 60 (if aged < 16 years)
Weight ≥ 40kg
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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: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
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 Belumosudil (KD025) will improve 1 primary outcome and 16 secondary outcomes in patients with Graft vs Host Disease. Measurement will happen over the course of Pre-dose and post-dose sampling within 12 hours..

Determine the area under the plasma concentration versus time curve (AUC) of belumosudil
PRE-DOSE AND POST-DOSE SAMPLING WITHIN 12 HOURS.
Area under the plasma concentration versus time curve (AUC)
Determine the Peak Plasma Concentration (Cmax) of belumosudil
PRE-DOSE AND POST-DOSE SAMPLING WITHIN 12 HOURS.
Determine the maximum plasma concentration (Cmax) of belumosudil
Determine the half-life (T1/2) of belumosudil
PRE-DOSE AND POST-DOSE SAMPLING WITHIN 12 HOURS.
The time it takes for half of belumosudil to be removed from plasma by biological processes (T1/2)
Determine the observed time to reach peak plasma concentration (Tmax) of belumosudil
PRE-DOSE AND POST-DOSE SAMPLING WITHIN 12 HOURS.
The time that belumosudil reach the maximum plasma concentration (Tmax).
Response rate by organ system
6 MONTHS
The response assessment for the nine individual organs (Skin, Eyes, Mouth, Esophagus, Upper GI, Lower GI, Liver, Lungs, and Joints and fascia).
Change in Lee Symptom Scale Score
6 MONTHS
Analyses will include: Number of subjects with a ≥7 point reduction, Number of subjects with a ≥7 point reduction on 2 consecutive assessments and Duration of a ≥7 point reduction. Symptom burden will be assessed on Day 1 of each cycle starting on Cycle 1 Day 1, as well as at the EOT visit. The questionnaire asks subjects to indicate the degree of bother that they experienced due to symptoms in seven domains potentially affected by chronic GVHD (skin, eyes, mouth, breathing, eating and digestion, energy, and emotional distress). The response will be determined based on clinician assessment specifically for each of affected organ as a Complete Response, Partial Response or Progression.
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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?

Recent findings shows, for the first time, that GvHD can be cured. After treatment is initiated the clinical course is favorable and survival may be over 90% with chronic GvHD. Recent findings may be of help to patients and their families.

Anonymous Patient Answer

What causes graft vs host disease?

T-cell mediated graft rejection causes Graft vs Host Disease. In adults with acute graft vs host disease, T-cell responses are usually directed towards major histocompatibility complex class I antigens. Allogeneic hematopoietic stem cell transplantation is contraindicated in people with HLA-matched donors.

Anonymous Patient Answer

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

Around 2 million patients a year are diagnosed with GVHD in the United States. These figures must be adjusted for the fact that the diagnostic criteria can be changed (and therefore numbers will change) without changes in the incidence of a disease. Results from a recent clinical trial presented here demonstrate the need to routinely and accurately record the incidence of each disease when it appears in a hospital set.

Anonymous Patient Answer

What are the signs of graft vs host disease?

GVHD can cause systemic symptoms in patients, including the following: fever, night sweats, swollen lymph nodes (often in combination with lymphadenopathy), jaundice, rash and a low white blood cell count. The clinical manifestations of systemic GVHD can be difficult to differentiate from post-transplant lymphoproliferative disorder (post-transplant lymphoproliferative disorder is treated differently from B-cell lymphoma). The mainstay of treatment is G-CSF.

Anonymous Patient Answer

What are common treatments for graft vs host disease?

Early treatment can reduce progression of acute GVHD to chronic disease; however, the use of steroids can lead to further progression of disease. To maintain remission, steroid treatment with oral cyclosporine A is important (the use of mycophenolate mofetil has been successful for some patients). Immunosuppressive treatment with anti-rabies antibodies is a very effective preventive therapy in cases of rabies. A Cochrane review on immunosuppressive agents in acute GVHD found that mycophenolate mofetil was the most promising drug. In the majority of cases, bone marrow transplantation can be recommended.

Anonymous Patient Answer

What is graft vs host disease?

GvHD may be categorized by the nature of the organ transplanted. This might have important consequences for the clinical management of organ-transplant recipients. The most common manifestation of chronic, and potentially life-threatening post-transplant GvHD is chronic diarrhea and skin lesions, mainly cutaneous vasculitis and skin ulcers.

Anonymous Patient Answer

Is belumosudil (kd025) typically used in combination with any other treatments?

Belumosudil was typically used in combination with other treatments. Belumosudil was not effective alone in reducing symptoms when used alone in treatment of ICBC. Belumosudil may be combined with other drugs in the future in development.

Anonymous Patient Answer

Does belumosudil (kd025) improve quality of life for those with graft vs host disease?

Treatment with kd025 (belumosudil) for GVHD is associated with significant improvement in physical and social QoL from baseline. Despite improvement in many physical symptoms of disease, patients who had the treatment of Belumosudil continued to experience significant pain and fatigue.

Anonymous Patient Answer

How serious can graft vs host disease be?

Graft vs host disease is serious. The potential for transplant-related death must be considered a main priority in the treatment of patients with GVHD, particularly at the time of engraftment.

Anonymous Patient Answer

What is the primary cause of graft vs host disease?

Graft vs host disease may be caused primarily by pregrafting exposures to an allogeneic environment, but may also result from an inability to effectively suppress alloreactive T lymphocytes. Our studies suggest that antigen-presenting cells, T cells, and innate immune cells are involved in the pathogenesis of GVHD, and that graft vs host disease requires the presence of 2 or more simultaneous infections.

Anonymous Patient Answer

What is the average age someone gets graft vs host disease?

Since this condition affects millions, studies needed to get a better understanding of how age affects the risk of getting graft vs host disease and how they can protect.\n

Anonymous Patient Answer

Does graft vs host disease run in families?

Graft-versus-host disease is a familial disease: the risk of GvHD in related patients seems to be significantly higher than in unrelated patients after BNHS. Since a positive correlation between GvHD and HLA homozygosity might be an underlying mechanism in this finding, the genetic predisposition of the host on top of these factors could have to be considered.

Anonymous Patient Answer
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