Condition: Indolent Systemic Mastocytosis · Smoldering Systemic Mastocytosis · Sponsor: Blueprint Medicines Corporation
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.
This description comes directly from the study's public registry record.
Blueprint Medicines · 617-714-6707 · medinfo@blueprintmedicines.com
Always discuss trial participation with your own doctor first.
| University of Alabama at Birmingham | Birmingham, Alabama, United States | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles, California, United States | Recruiting |
| Stanford Cancer Institute | Palo Alto, California, United States | Recruiting |
| UCHealth Blood Disorders and Cell Therapies Center - Anschutz Medical Campus | Aurora, Colorado, United States | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta, Georgia, United States | Recruiting |
| Brigham and Women's Hospital | Boston, Massachusetts, United States | Recruiting |
| Michigan Medicine University of Michigan | Ann Arbor, Michigan, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Roswell Park Cancer Institute | Buffalo, New York, United States | Recruiting |
| Columbia University Medical Center | New York, New York, United States | Recruiting |
| Duke Asthma, Allergy and Airway Center | Durham, North Carolina, United States | Recruiting |
| University of Cincinnati Medical Center | Cincinnati, Ohio, United States | Recruiting |
+ 59 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04910685