An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01833039 |
Expanded Access Status :
Approved for marketing
First Posted : April 16, 2013
Last Update Posted : November 7, 2018
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Condition or disease | Intervention/treatment |
---|---|
Relapsed or Refractory Mantle Cell Lymphoma | Drug: Ibrutinib |
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 |

- Drug: Ibrutinib
Ibrutinib

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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

Responsible Party: | Janssen Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT01833039 |
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 |
Mantle Cell Lymphoma Ibrutinib |
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |