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

January 31, 2025 updated by: Janssen Biotech, Inc.

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

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Barretos, Brazil
      • Florianopolis, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Duarte, California, United States
      • Los Angeles, California, United States
      • Stanford, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Norwalk, Connecticut, United States
      • Stamford, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Miami Beach, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Goshen, Indiana, United States
    • Iowa
      • Sioux City, Iowa, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • Jefferson City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • Nevada
      • Reno, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
    • New York
      • New Hyde Park, New York, United States
      • New York, New York, United States
      • Syracuse, New York, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
    • South Dakota
      • Watertown, South Dakota, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Houston, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • West Virginia
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Biotech, Inc.

Collaborators

Pharmacyclics LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

April 6, 2013

First Submitted That Met QC Criteria

April 15, 2013

First Posted (Estimated)

April 16, 2013

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR101862
  • PCI-32765MCL4001 (Other Identifier: Janssen)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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