Elenestinib: Elenestinib oral tablet
Placebo: Placebo oral tablet
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.
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| David Geffen School of Medicine at UCLA | Los Angeles | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| UCHealth Blood Disorders and Cell Therapies Center - Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Michigan Medicine University of Michigan | Ann Arbor | Michigan | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Duke Asthma, Allergy and Airway Center | Durham | North Carolina | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Huntsman Cancer Institute, University of Utah | Salt Lake City | Utah | Recruiting |
| CHP Centro Hematologico Pavlovsky | Buenos Aires | Argentina | Recruiting |
| Consultorios Medicos Dr. Doreski - Fundacion Respirar | Buenos Aires | Argentina | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Kepler Universitatsklinikum, Med Campus III. Clinic of Internal Medicine 3 - Hematology and Oncology | Linz | Austria | Recruiting |
| Unitversitair Ziekenhuis Antwerpen | Edegem | Antwerpen | Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Recruiting |
| CHU Tivoli | La Louvière | Belgium | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP | São Paulo | Brazil | Recruiting |
| Fundación Valle del Lili | Cali | Colombia | Recruiting |
| Fakultní nemocnice Brno, Interní hematologická a onkologická klinika | Brno | Czechia | Recruiting |
| Fakultní nemocnice Královské Vinohrady, Hematologická klinika 3. LF UK v Praze a FNKV | Prague | Czechia | Recruiting |
| CHU Amiens-Picardie | Amiens | France | Recruiting |
| CHU de Caen | Caen | France | Recruiting |
| CHU Grenoble | Grenoble | France | Recruiting |
| CHU de Limoges | Limoges | France | Recruiting |
| CHU de Nantes | Nantes | France | Recruiting |
| Hôpital de la Pitié Salpétrière | Paris | France | Recruiting |
| Hôpital Necker - Départementd 'HématologieA dultes | Paris | France | Recruiting |
| CHU de Poitiers | Poitiers | France | Recruiting |
| CHU Toulouse - Hopital Larrey | Toulouse | France | Recruiting |
| Universitätsklinikum RWTH Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation | Aachen | Germany | Recruiting |
| Charité - Universitätsmedizin Berlin Institute of Allergology | Berlin | Germany | Recruiting |
| University Clinic Erlangen | Erlangen | Germany | Recruiting |
| University Clinic Hamburg Eppendorf | Hamburg | Germany | Recruiting |
| Universitätsmedizin Mannheim III. Medizinische Klinik Universität Heidelberg Medizinische Fakultät Mannheim | Mannheim | Germany | Recruiting |
+ 35 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04910685 on ClinicalTrials.gov ↗ ← All trials in the UK