Spots Global Cancer Trial Database for (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
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Trial Identification
Brief Title: (HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis
Study ID: NCT04910685
Study Description
Brief Summary: This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of 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 BLU-263 in an open-label fashion following completion of the earlier Part. Part M will enroll patients with monoclonal mast cell activation syndrome (mMCAS). The study also includes PK groups that will enroll patients with ISM.
Detailed Description:
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Stanford Cancer Institute, Palo Alto, California, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Michigan Medicine University of Michigan, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Kepler Universitatsklinikum, Med Campus III. Clinic of Internal Medicine 3 - Hematology and Oncology, Linz, , Austria
Unitversitair Ziekenhuis Antwerpen, Edegem, Antwerpen, Belgium
CHU Amiens-Picardie, Amiens, , France
CHU de Caen, Caen, , France
CHU Grenoble, Grenoble Cedex 9, , France
CHU de Limoges, Limoges Cedex, , France
CHU de Nantes, Nantes, , France
Hôpital de la Pitié Salpétrière, Paris, , France
Hôpital Necker - Départementd 'HématologieA dultes, Paris, , France
CHU de Poitiers, Poitiers, , France
CHU Toulouse - Hopital Larrey, Toulouse, , France
Universitätsklinikum RWTH Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Aachen, , Germany
Charité - Universitätsmedizin Berlin Institute of Allergology, Berlin, , Germany
University Clinic Erlangen, Erlangen, , Germany
University Clinic Hamburg Eppendorf, Hamburg, , Germany
Universitätsmedizin Mannheim III. Medizinische Klinik Universität Heidelberg Medizinische Fakultät Mannheim, Mannheim, , Germany
LMU Klinikum, Munich, , Germany
Dipartimentod i Oncoematologia Istituto Scientifico Romagnolop er lo studio e la cura dei tumori (IRST)- IRCCS, Meldola, Forli-Cesena, Italy
UOC Ematologia, Milano, Lombardia, Italy
SOD Ematologia (Ambulatori)- AOUC Azienda Ospedaliero Universitaria Careggi, Firenze, Toscana, Italy
Unita Operativa di Ematologia AOU Policlinico S. Orsola-Malpighi, Bologna, , Italy
S.C. Ematologia Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy
S.S.D. Immunologia Clinica e Allergologia Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona, Salerno, , Italy
Unità Operativa di Allergologia Azienda Ospedaliera Universitaria Integrata di Verona, Verona, , Italy
ErasmusMC, Rotterdam, Zuid-Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Oslo University Hospital, Oslo, , Norway
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos, Lisbon, , Portugal
CHUPorto, EPE - Hospital de Santo António, Porto, , Portugal
Centro Hospitalar Universitario Sao Joao, E.P.E., Porto, , Portugal
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Virgen del Valle - Instituto de Estudios de Mastocitosis de Castilla-La Mancha, Toledo, , Spain
University Hospital Basel, Basel, , Switzerland
Luzerner Kantonsspital, Luzern, , Switzerland
University Hospital of Wales, Cardiff, Wales, United Kingdom
Cancer and Haematology Centre, Oxford, , United Kingdom
Contact Details
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