Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.



Status:Enrolling by invitation
Conditions:Cancer, Lymphoma, Lymphoma, Orthopedic, Hematology
Therapuetic Areas:Hematology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:May 22, 2017
End Date:July 2, 2027

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Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

Multicenter, open-label, prospective treatment protocol that provides continued access to
ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from
treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying
disease within their region.

Multicenter, open-label, prospective treatment protocol that provides continued access to
ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from
treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying
disease within their region.

Subjects enrolled in this treatment protocol will receive oral continuous dosing with
ibrutinib at the same dose and schedule they were receiving at the end of the respective
parent study. Treatment may be continued as long as the subjects continue to derive benefit
from treatment with ibrutinib until such time that ibrutinib becomes commercially available
for the indication of the parent study.

Clinical evaluations (including safety assessments) will be performed per local standard of
care for each disease that was studied in the parent protocol. At each visit, all ongoing and
new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse
events (SAEs), adverse events of special interest (AESI), pregnancy events, other
malignancies, and special reporting situations will be recorded.

Inclusion Criteria:

- Subject must currently be participating in an ibrutinib clinical trial, deriving
clinical benefit from treatment with ibrutinib in the opinion of the treating
physician and do not have access to commercial ibrutinib within their region.

- Ongoing continuous treatment with ibrutinib.

- Subject must have completed all assessments in their parent protocol and want to
continue treatment with ibrutinib.

- Subject has provided informed consent.

- Male and female subjects of reproductive potential who agree to use both a highly
effective method of birth control and a barrier method during the period of therapy
and for 90 days after the last dose of drug.

Exclusion Criteria:

- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib
treatment.

- Any condition or situation which, in the opinion of the treating physician, may
interfere significantly with a subject's participation in the protocol.

- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant.
Male subjects who plan to father a child while enrolled in this protocol.
We found this trial at
35
sites
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Burlington, Vermont 05405
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303 East Superior Street
Chicago, Illinois 60611
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Columbus, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48202
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Eugene, OR
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Hackensack, New Jersey 07601
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Hradec Králové, Kralovehradecky Kraj 50005
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La Jolla, California 92093
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Lake Success, New York 11042
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3730 South Eastern Avenue
Las Vegas, Nevada 89169
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Los Angeles, California 90095
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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New Brunswick, New Jersey 08903
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New Hyde Park, New York 11040
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19104
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tyler, Texas 75702
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Vancouver, WA
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Yakima, Washington
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