Real-world experience with vimseltinib for tenosynovial giant cell tumor
Real-World Patient Experience of Vimseltinib for the Treatment of Tenosynovial Giant Cell Tumor
Deciphera Pharmaceuticals, LLC · NCT07075471
This registry will collect real-world information about how people with TGCT take vimseltinib and how it affects their symptoms and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deciphera Pharmaceuticals, LLC (industry) |
| Drugs / interventions | vimseltinib |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT07075471 on ClinicalTrials.gov |
What this trial studies
This observational registry will collect medical record data and patient-reported outcomes from people with TGCT who are prescribed vimseltinib without changing their care. Eligible participants must have a confirmed TGCT diagnosis and either plan to start vimseltinib or have begun it within the past six months; those who received other systemic TGCT therapies in the six months before starting vimseltinib or who are enrolled in an interventional vimseltinib trial are excluded. Data captured will include treatment patterns, dosing and timing, adverse events, and health-related quality of life measures. The sponsor is Deciphera Pharmaceuticals and enrollment is conducted at a Synexus Clinical Research site in Wilmington, North Carolina.
Who should consider this trial
Good fit: People with a confirmed diagnosis of TGCT who have been prescribed vimseltinib and are about to start it or began it within the last six months and who can provide informed consent and medical record release.
Not a fit: People who started vimseltinib more than six months before enrollment, who received other systemic TGCT treatments within six months prior to starting vimseltinib, or who are enrolled in an interventional vimseltinib trial are not eligible and therefore will not receive benefits from participating in this registry.
Why it matters
Potential benefit: Could provide clinicians and patients clearer, real-world information on vimseltinib’s side effects, usage patterns, and impact on quality of life.
How similar studies have performed: Real-world registries and prior clinical trials of CSF1R-targeting therapies such as pexidartinib have produced useful safety and quality-of-life data, so this registry builds on established approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of TGCT according to medical records 2. Prescribed vimseltinib per the approved label requirements. Participants are eligible if either (A) the decision to receive vimseltinib has been made but treatment has not yet been initiated or (B) the decision to receive vimseltinib has been made and participant has received first dose of prescribed vimseltinib less than 6 months prior to study enrollment 3. Has provided informed consent and medical records release Exclusion Criteria: 1. Participant has received any other systemic agent for the treatment of TGCT during the 6 months prior to starting treatment with vimseltinib 2. Participant has received the first dose of prescribed vimseltinib in the current treatment course more than 6 months before study enrollment 3. Participant is active in an interventional clinical trial of vimseltinib
Where this trial is running
Wilmington, North Carolina
- Synexus Clinical Research, US INC — Wilmington, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Clinical Team
- Email: clinicaltrials@deciphera.com
- Phone: 888-724-3274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tenosynovial Giant Cell Tumor