(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

251

Participants

Timeline

Start Date

April 16, 2019

Primary Completion Date

June 23, 2027

Study Completion Date

June 23, 2027

Conditions
Indolent Systemic Mastocytosis
Interventions
DRUG

Avapritinib

Avapritinib tablet

DRUG

Placebo

Placebo tablet

Trial Locations (49)

2650

University Hospital Antwerp, Edegem

4031

University Hospital Basel, Basel

10032

Herbert Irving Comprehensive Cancer Center, New York

10117

Charité Universitätsmedizin Berlin, Berlin

13385

Hôpital de la Timone, Service de dermatologie, Marseille

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Poloclinico, UOC Ematologia, Milan

20246

University Clinic Hamburg Eppendorf, University Cancer Center Hamburg (UCCH), Hamburg

23298

Virginia Commonwealth University Medical Center, Richmond

23538

Universitätsklinikum Schleswig-Holstein, Hämatologie/Onkologie, Lübeck

27710

Duke University Health System (DUHS), Durham

30322

Winship Cancer Institute, Emory University, Atlanta

31059

CHU Toulouse Larrey, CEREMAST, Service de Dermatologie et Allergologie cutanée, Toulouse

32224

Mayo Clinic Florida, Jacksonville

33612

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama at Birmingham, Birmingham

37126

Azienda Ospedaliera Universitaria Integrata di Verona, Verona

40138

A.O.U di Bologna - IRCCS, Istituto di Ematologia Lorenzo e Ariosto Seragnoli, Ematologia, Bologna

44106

University Hospitals Cleveland Medical Center, Cleveland

45071

lnstituto de Estudios de Mastocitosis de Castilla la Mancha, Hospital Virgen del Valle - Complejo Hospitalario de Toledo, Toledo

48106

Michigan Medicine, University of Michigan, Ann Arbor

52074

Uniklinik RWTH Aachen, Aachen

55131

Universitätsklinik Mainz, Universitäts-Hautklinik, Clinical Research Center, Mainz

55905

Mayo Clinic, Rochester

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Hospital, Kansas City

68167

Universitätsmedizin Mannheim, III. Medizinische Klinik, Mannheim

75013

Hôpital Pitié-Salpêtrière, Service de Dermatologie, Paris

77030

University of Texas, MD Anderson Cancer Center, Houston

80802

Klinikum rechts der Isar, Technische Universität München, Munich

84112

Huntsman Cancer Institute, Salt Lake City

84131

A.O. OO.RR. S.Giovanni di Dio e Ruggi d'Aragona, University of Salerno, Salerno

85054

Mayo Clinic Hospital, Phoenix

94305

Stanford Cancer Institute, Stanford

02115

Brigham & Women's Hospital, Boston

02215

Dana Farber Cancer Institute, Boston

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

M5B 1W8

St. Michael's Hospital, Toronto

DK-5000

Odense Universitetshospital, ORCA/Allergicentret, Hudafdeling I og Allergicenter, Odense

9713 GZ

University Medical Center Groningen (UMCG), Groningen

3015 GD

Erasmus Medical Center, Rotterdam

0372

Oslo Universitetssykehus, Rikshospitalet, Department of Hematology, Oslo

08035

Hospital Universitari Vall d'Hebron, Barcelona

141 86

Karolinska University Hospital, Hematologimottagningen R51, Stockholm

751 85

Akademiska sjukhuset, Hematologmottagningen/101A, Uppsala

G12 OXL

NHS Greater Glasgow and Clyde, Beatson West of Scotland Cancer Centre, Glasgow

SE1 9RT

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital, London

CH63 4JY

Clatterbridge Cancer Centre NHS Foundation Trust, Metropolitan Borough of Wirral

All Listed Sponsors
lead

Blueprint Medicines Corporation

INDUSTRY