Study #2022-0072
A Randomized Double-Blind Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis
MD Anderson Study Status
Enrolling
Treatment Agent
Elenestinib, Placebo
Description
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. Parts 1 and 2 will enroll patients with ISM. Patients enrolled in Part 1 or 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 M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). Part S will enroll participants with smoldering systemic mastocytosis (SSM). The study also includes PK groups that will enroll patients with ISM.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Indolent Systemic Mastocytosis, Monoclonal Mast Cell Activation Syndrome, Smoldering Systemic Mastocytosis
Study phase:
Phase II/III
Physician name:
Hussein Abbas
Department:
Leukemia
For general questions about clinical trials:
1-877-632-6789
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