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 |
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.
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.
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
University of Chicago One of the world's premier academic and research institutions, the University of...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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501 South Buena Vista Street
Burbank, California 91505
Burbank, California 91505
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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1500 East Duarte Road
Duarte, California 91010
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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500 University Dr
Hershey, Pennsylvania 17033
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
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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1475 NW 12th Ave
Miami, Florida 33136
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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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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660 S Euclid Ave
Saint Louis, Missouri 63110
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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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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