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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Administered orally
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLTs assessed for each dose level.
Time frame: Cycle 1 (28 Days)
Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)
AEs and SAEs assessed for each dose level.
Time frame: Baseline to Study Completion (Estimated up to 24 months)
Objective Response Rate (ORR)
ORR is percentage of participants achieving best overall response of complete response (CR) or partial response (PR) up to Cycle 7 Day 1 based on 2014 National Institutes of Health (NIH) cGVHD Criteria.
Time frame: Baseline up to Cycle 7 Day 1 (Cycle = 28 days)
Duration of Response (DOR)
DOR for participants with CR or PR, defined as the time interval from the time of first CR or PR per 2014 NIH cGVHD Criteria, until PD, initiation of new systemic therapy for cGVHD, or death due to any cause, whichever occurs first.
Time frame: First CR or PR until PD or Death due to Any Cause (Estimated up to 24 months)
Organ-Specific Response
Organ-specific response per 2014 NIH cGVHD Criteria up to Cycle 7 Day 1
Time frame: Baseline up to Cycle 7 Day 1 (Cycle = 28 days)
Failure-Free Survival (FFS)
FFS is the time from first dose to progressive disease (PD) per 2014 NIH cGVHD Criteria, initiation of new systemic therapy for cGVHD, or death due to any cause, whichever occurs first.
Time frame: Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months)
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City of Hope National Medical Center
Duarte, California, United States
RECRUITINGRonald Regan UCLA Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of California Irvine Health
Orange, California, United States
RECRUITINGAdventHealth Orlando
Orlando, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGUniversity of Illinois Medical Center - Hematology & Oncology
Chicago, Illinois, United States
RECRUITINGUniversity of Kansas Cancer Center-Westwood
Westwood, Kansas, United States
RECRUITINGUniversity of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITING...and 16 more locations
Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
Cmax
Time frame: Estimated up to 24 months