Janssen Biotech, Inc.

An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Official Title: 
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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.
Approved for marketing
EA Type
Treatment IND/Protocol
Relapsed or Refractory Mantle Cell Lymphoma

Drug: Ibrutinib

Eligibility Criteria: 

Inclusion Criteria:

- Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.

Exclusion Criteria:

- 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.

Eligibility Gender: 
Eligibility Age: 
Minimum: 18 Years
Brazil, Puerto Rico, United States

Phoenix, Arizona,

Duarte, California,

La Jolla, California,

Los Angeles, California,

Stanford, California,

Denver, Colorado,

Norwalk, Connecticut,

Stamford, Connecticut,

Washington, District of Columbia,

Brandon, Florida,

Miami Beach, Florida,

Ocala, Florida,

Orlando, Florida,

Palm Beach Gardens, Florida,

Atlanta, Georgia,

Chicago, Illinois,

Springfield, Illinois,

Goshen, Indiana,

Sioux City, Iowa,

Lexington, Kentucky,

Louisville, Kentucky,

Metairie, Louisiana,

Baltimore, Maryland,

Boston, Massachusetts,

Worcester, Massachusetts,

Ann Arbor, Michigan,

Detroit, Michigan,

Rochester, Minnesota,

Jefferson City, Missouri,

Saint Louis, Missouri,

Lincoln, Nebraska,

Omaha, Nebraska,

Reno, Nevada,

Hackensack, New Jersey,

New Hyde Park, New York,

New York, New York,

Syracuse, New York,

Durham, North Carolina,

Cleveland, Ohio,

Columbus, Ohio,

Hershey, Pennsylvania,

Philadelphia, Pennsylvania,

Pittsburgh, Pennsylvania,

Watertown, South Dakota,

Knoxville, Tennessee,

Nashville, Tennessee,

Austin, Texas,

Dallas, Texas,

Houston, Texas,

Lubbock, Texas,

Burlington, Vermont,

Charlottesville, Virginia,

Morgantown, West Virginia,

Madison, Wisconsin,

Janssen Biotech, Inc.
Pharmacyclics LLC.
EA Number: 
Mantle Cell Lymphoma, Ibrutinib
MeSH Terms: 
Lymphoma, Lymphoma, Mantle-Cell
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