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

This study is ongoing, but not recruiting participants.
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Biotech, Inc. Identifier:
First received: April 6, 2013
Last updated: May 12, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Relapsed or Refractory Mantle Cell Lymphoma
Drug: Ibrutinib
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • Percentage of Patients With Treatment Emergent Adverse Experiences during the study. [ Time Frame: Start of study drug to 30 Days post study drug administration ]
    Percentage of Patients With Treatment Emergent Adverse Experiences during the study.

Enrollment: 163
Actual Study Start Date: May 15, 2013
Estimated Study Completion Date: July 31, 2017
Estimated Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibrutinib
Drug: Ibrutinib


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01833039

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

Responsible Party: Janssen Biotech, Inc. Identifier: NCT01833039     History of Changes
Other Study ID Numbers: CR101862
PCI-32765MCL4001 ( Other Identifier: Janssen )
Study First Received: April 6, 2013
Last Updated: May 12, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Biotech, Inc.:
Mantle Cell Lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on May 25, 2017