An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
2 other identifiers
expanded_access
N/A
3 countries
51
Brief Summary
The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedFebruary 3, 2025
January 1, 2025
April 6, 2013
January 31, 2025
Conditions
Keywords
Interventions
Ibrutinib
Eligibility Criteria
You may qualify if:
- Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.
You may not qualify if:
- Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible.
- Patients previously treated with ibrutinib are not eligible.
- Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Biotech, Inc.lead
- Pharmacyclics LLC.collaborator
Study Sites (51)
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Phoenix, Arizona, United States
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Duarte, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Denver, Colorado, United States
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Norwalk, Connecticut, United States
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Stamford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Goshen, Indiana, United States
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Sioux City, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Metairie, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Hackensack, New Jersey, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Syracuse, New York, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Watertown, South Dakota, United States
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Knoxville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Burlington, Vermont, United States
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Morgantown, West Virginia, United States
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Barretos, Brazil
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Florianópolis, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São Paulo, Brazil
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San Juan, Puerto Rico