Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

PHASE3CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

July 7, 2014

Primary Completion Date

November 7, 2019

Study Completion Date

November 7, 2019

Conditions
Waldenström's Macroglobulinemia
Interventions
DRUG

Ibrutinib

Participants will receive 420 mg of Ibrutinib orally.

DRUG

Placebo

Participants will receive placebo capsules orally.

DRUG

Rituximab

Participants will receive rituximab 375 mg/m\^2 IV.

Trial Locations (48)

2139

Concord Repartriation General Hospital, Concord

2605

The Canberra Hospital, Garran

3000

Peter MacCallum Cancer Center, Melbourne

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical Center, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin

11527

Laiko General Hospital of Athens, Athens

11528

Alexandra Hospital, Athens

13273

Institut Paoli-Calmettes, Marseille

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

22027

Centre Hospitalier de Saint Brieuc Hopital Yves le Foll, Saint-Brieuc

26500

University General Hospital of Patras, Pátrai

27100

ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

28031

Hospital Universitario Infanta Leonor, Madrid

28239

DIAKO Evangelische Diakonie Krankenhaus gGmbH, Bremen

30322

Emory University Hospital, Atlanta

33100

Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine, Udine

37007

Hospital Universitario de Salamanca, Salamanca

37204

Vanderbilt University Medical Center, Nashville

44093

Hôtel Dieu, Nantes

54511

CHU de Nancy-Hopital Brabois Adulte, Vandœuvre-lès-Nancy

54621

"University General Hospital of Thessaloniki AHEPA", Thessaloniki

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

59037

Hôpital Claude Huriez, Lille

60611

Northwestern Memorial Hospital, Chicago

63000

CHU Estaing, Clermont-Ferrand

66421

Universität Des Saarlandes, Homburg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

73557

Stauferklinikum Schwäbisch Gmünd, Mutlangen

75010

Hôpital Saint Louis, Paris

80218

Colorado Blood Cancer Institute, Denver

81377

LMU Klinikum der Universität München, München

90404

University of California Los Angeles, Los Angeles

94010

Hopital Henri Mondor, Créteil

94305

Stanford Cancer Center, Palo Alto

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

05042

Flinders Medical Center, Bedford Park

T6G1Z2

Cross Cancer Institute, Edmonton

B3H 2Y9

Queen Elizabeth II Health Sciences Center, Halifax

M5G 2M9

Princess Margaret Hospital, Toronto

H4A3J1

McGill University Health Center, Montreal

75651 Cedex 13

Groupe Hospitalier Pitié Salpétrière, Paris

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08036

Hospital Clinic de Barcelona, Barcelona

08041

Hospital de La Santa Creu i Sant Pau, Barcelona

BH7 7DW

Royal Bournemouth Hospital, Bournemouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY