Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:60 - Any
Updated:12/22/2018
Start Date:January 2017
End Date:January 2025
Contact:Silvie Aarts
Email:medinfo@pcyc.com
Phone:+1- 669- 224- 1860

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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)

The purpose of this study is to evaluate whether the addition of ibrutinib will result in
prolongation of progression-free survival (PFS) when compared with rituximab alone in
treatment naïve subjects with follicular lymphoma.


Inclusion Criteria:

- Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann
Arbor Stage II, III or IV disease.

- Measurable disease

- Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more
comorbidities.

- Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.

- Adequate hematologic function within protocol-defined parameters.

- Adequate hepatic and renal function within protocol-defined parameters.

- ECOG performance status score of 0-2.

Exclusion Criteria:

- Transformed lymphoma

- Prior treatment for follicular lymphoma

- Central nervous system lymphoma or leptomeningeal disease

- Currently active, clinically significant cardiovascular disease
We found this trial at
44
sites
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Harvey, IL
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Sioux Falls, SD
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Beaverton, OR
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810 Hospital Drive
Blacksburg, Virginia 24060
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Burbank, CA
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Chattanooga, Tennessee 37404
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524 North Boonville Avenue
Chesterfield, Missouri 65806
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cincinnati, OH
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Columbus, OH
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Duarte, California 91010
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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800 West Magnolia Avenue
Fort Worth, Texas 76104
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Greenville, South Carolina 29615
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Houston, Texas 77030
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Jefferson City, Missouri 65109
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Kansas City, Missouri 64131
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400 North Stephanie Street
Las Vegas, Nevada 89014
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Lincoln, Nebraska 68510
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Louisville, Kentucky 40207
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Mobile, Alabama 36608
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Morgantown, West Virginia 26506
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Morristown, New Jersey 07960
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1100 Charlotte Avenue
Nashville, Tennessee 37203
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New Orleans, Louisiana 70112
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
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Ocala, Florida 34471
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19646 North 27th Avenue
Phoenix, Arizona 85027
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Saint Petersburg, Florida 33705
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Santa Barbara, California 93105
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Santa Monica, California 90404
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Seattle, Washington 98104
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Sherman, Texas 75090
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Spokane, Washington 99208
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Springfield, Missouri 65806
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Tyler, Texas 75702
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1309 North Flagler Drive
West Palm Beach, Florida 33407
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Ypsilanti, Michigan 48197
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