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

NCT ID: NCT01833039

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed or Refractory Mantle Cell Lymphoma

Interventions

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Ibrutinib

Ibrutinib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacyclics LLC.

INDUSTRY

Sponsor Role collaborator

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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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

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Countries

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United States Brazil Puerto Rico

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=4530&filename=CR101862_CSR.pdf

An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Other Identifiers

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PCI-32765MCL4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR101862

Identifier Type: -

Identifier Source: org_study_id

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