Vimseltinib for Active Chronic Graft-Versus-Host Disease
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
Recruiting
Phase 2Interventional Study
Chronic Graft-Versus-Host Disease (cGVHD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
48 (estimated)
Sponsor
Deciphera Pharmaceuticals, LLC · Industry
Who this trial is looking for
This trial is looking for adults with moderate to severe chronic graft-versus-host disease (cGVHD) who have not responded to other treatments. Participants will take a medication called vimseltinib for about two years.
Are You a Good Fit for This Trial?
You may be able to join if
I have received an allogeneic stem cell transplant.
I have moderate to severe cGVHD needing treatment.
I have actively tried at least 2 other systemic treatments without success.
I am stable on my current dose of corticosteroids for at least 2 weeks.
I have adequate organ and bone marrow function.
I agree to follow contraception requirements.
I have a Karnofsky Performance Scale score of 60 or higher.
You may not be able to join if
I have acute graft-versus-host disease without cGVHD.
I have used a CSF1R inhibitor for cGVHD in the past.
I have a severe illness or uncontrolled infection.
I have a history of certain types of cancer unless I meet specific criteria.
I have a malabsorption syndrome or any illness affecting how medicine is absorbed.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
2. Participants with a…
Inclusion Criteria:
1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).
2. Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
3. Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
4. Adequate organ and bone marrow functions.
5. Participants of reproductive potential agree to follow the contraception requirements.
6. Karnofsky Performance Scale (KPS) of ≥60.
Exclusion Criteria:
1. Has aGVHD without manifestations of cGVHD.
2. Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
3. History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence.
4. History of malignancy except for:
1. Underlying malignancy for which the transplant was performed
2. Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
5. Malabsorption syndrome or other illness that could affect oral absorption.
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