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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.
Information provided by (Responsible Party):
Janssen Biotech, Inc. Identifier:
First received: April 6, 2013
Last updated: March 15, 2016
Last verified: March 2016
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: Open Label
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 ] [ Designated as safety issue: Yes ]
    Percentage of Patients With Treatment Emergent Adverse Experiences during the study.

Enrollment: 163
Study Start Date: May 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibrutinib
Drug: Ibrutinib


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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Phoenix, Arizona, United States
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Duarte, California, United States
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San Juan, Puerto Rico
Sponsors and Collaborators
Janssen Biotech, Inc.
  More Information

Responsible Party: Janssen Biotech, Inc. Identifier: NCT01833039     History of Changes
Other Study ID Numbers: CR101862  PCI-32765MCL4001 
Study First Received: April 6, 2013
Last Updated: March 15, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 26, 2016