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Compares treatment options for Chronic Graft-Versus-Host Disease (cGVHD)
Official title A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
ClinicalTrials.gov ID: NCT06619561
What this study is testing
What is Vimseltinib?
Vimseltinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic graft-versus-host disease (cgvhd).
Also referred to as DCC-3014.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression. a. May...
- Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
- Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for...
- Adequate organ and bone marrow functions.
- Participants of reproductive potential agree to follow the contraception requirements.
You likely can't join if
- Has aGVHD without manifestations of cGVHD.
- Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
- History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the...
- History of malignancy except for:
- Underlying malignancy for which the transplant was performed
- 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...
See the full eligibility criteria
- 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)...
- Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
- 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.
- Adequate organ and bone marrow functions.
- Participants of reproductive potential agree to follow the contraception requirements.
- Karnofsky Performance Scale (KPS) of ≥60.
- Has aGVHD without manifestations of cGVHD.
- Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
- 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.
- History of malignancy except for:
- Underlying malignancy for which the transplant was performed
- 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.
- Malabsorption syndrome or other illness that could affect oral absorption.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Westwood, Kansas, United States
- Lexington, Kentucky, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Los Angeles, California, United States; Orange, California, United States; Orlando, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.