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Brief Title: Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia
Official Title: iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia
Study ID: NCT02165397
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California Los Angeles, Los Angeles, California, United States
Stanford Cancer Center, Palo Alto, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
Emory University Hospital, Atlanta, Georgia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical Center, New York, New York, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
The Canberra Hospital, Garran, Australian Capital Territory, Australia
Concord Repartriation General Hospital, Concord, New South Wales, Australia
Flinders Medical Center, Bedford Park, South Australia, Australia
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
Cross Cancer Institute, Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Institut Paoli-Calmettes, Marseille, Bouches-du-Rhône, France
Centre Hospitalier de Saint Brieuc Hopital Yves le Foll, Saint-Brieuc, Finistère, France
Hôtel Dieu, Nantes, Loire-Atlantique, France
CHU de Nancy-Hopital Brabois Adulte, Vandoeuvre-lès-nancy, Meurthe-et-Moselle, France
Hôpital Claude Huriez, Lille, Nord, France
CHU Estaing, Clermont-Ferrand, Puy-de-Dôme, France
Centre Hospitalier Lyon Sud, Pierre-benite, Rhône, France
Hopital Henri Mondor, Créteil, , France
Hôpital Saint Louis, Paris, , France
Groupe Hospitalier Pitié Salpétrière, Paris, , France
Stauferklinikum Schwäbisch Gmünd, Mutlangen, Baden-Württemberg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Rheinland-Pfalz, Germany
Universität Des Saarlandes, Homburg, Saarland, Germany
DIAKO Evangelische Diakonie Krankenhaus gGmbH, Bremen, , Germany
LMU Klinikum der Universität München, München, , Germany
University General Hospital of Patras, Patras, Achaia, Greece
Alexandra Hospital, Athens, Attiki, Greece
University General Hospital of Thessaloniki "AHEPA", Thessaloniki, Macedonia, Greece
Laiko General Hospital of Athens, Athens, , Greece
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia, , Italy
Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine, Udine, , Italy
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario de Salamanca, Salamanca, Castilla Y León, Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Royal Bournemouth Hospital, Bournemouth, Dorset, United Kingdom
Name: Bernhard Hauns, MD
Affiliation: Pharmacyclics LLC (An AbbVie Company)
Role: STUDY_DIRECTOR