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

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ClinicalTrials.gov Identifier: NCT01833039
Expanded Access Status : Approved for marketing
First Posted : April 16, 2013
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Biotech, Inc.

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.

Condition or disease Intervention/treatment
Relapsed or Refractory Mantle Cell Lymphoma Drug: Ibrutinib

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



Intervention Details:
  • Drug: Ibrutinib
    Ibrutinib

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833039


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Sponsors and Collaborators
Janssen Biotech, Inc.
Pharmacyclics LLC.

Additional Information:
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Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01833039     History of Changes
Other Study ID Numbers: CR101862
PCI-32765MCL4001 ( Other Identifier: Janssen )
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: October 2018
Keywords provided by Janssen Biotech, Inc.:
Mantle Cell Lymphoma
Ibrutinib
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin