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Tyrosine Kinase Inhibitor
Vimseltinib for Chronic Graft-Versus-Host Disease
Phase 2
Recruiting
Research Sponsored by Deciphera Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
6. Karnofsky Performance Scale (KPS) of ≥60.
1. Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test if vimseltinib is safe and effective in treating adults with a specific type of chronic graft-versus-host disease. Patients will receive vimseltinib treatment for
Who is the study for?
This trial is for adults with active moderate to severe chronic Graft-Versus-Host Disease (cGVHD) after stem cell transplant. They must have tried at least two other treatments without success, be able to do most activities (KPS ≥60), and may still have some acute GVHD symptoms. Stable use of steroids is okay, and they need good organ/bone marrow function.
What is being tested?
The study tests Vimseltinib's safety and effectiveness in treating cGVHD over approximately 2 years. Participants will undergo treatment cycles lasting 28 days each with the goal of reducing the severity of their condition.
What are the potential side effects?
While specific side effects are not listed here, common ones for drugs like Vimseltinib could include nausea, diarrhea, fatigue, liver issues, skin reactions or increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may need occasional help.
Select...
I received a stem cell transplant and need treatment for a severe reaction.
Select...
I have chronic GVHD and two treatments haven't worked for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ estimated up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
Number of Participants with Dose-Limiting Toxicities (DLTs)
Secondary study objectives
Duration of Response (DOR)
Failure-Free Survival (FFS)
Objective Response Rate (ORR)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: VimseltinibExperimental Treatment1 Intervention
Escalating doses of vimseltinib in 28 day cycles.
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Who is running the clinical trial?
Deciphera Pharmaceuticals, LLCLead Sponsor
18 Previous Clinical Trials
2,121 Total Patients Enrolled
Clinical TeamStudy DirectorDeciphera Pharmaceuticals, LLC
4 Previous Clinical Trials
441 Total Patients Enrolled