An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Phase 4
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Mantle Cell Lymphoma
Both
Relapsed or Refractory Mantle Cell Lymphoma
Trial Information
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Inclusion Criteria:
- Patients, 18 years of age and older, with Mantle Cell Lymphoma who have progressive
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.
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percentage of Patients With Treatment Emergent Adverse Experiences during the study.
Outcome Description:
Percentage of Patients With Treatment Emergent Adverse Experiences during the study.
Outcome Time Frame:
Start of study drug to 30 Days post study drug administration
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
CR101862
NCT ID:
NCT01833039
Start Date:
April 2013
Completion Date:
May 2014
Related Keywords:
- Relapsed or Refractory Mantle Cell Lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Bettendorf, Iowa 52722 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Metairie, Louisiana 70006 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| South Burlington, Vermont | |
| Milwaukee, Wisconsin | |
| Indianapolis, Indiana | |
| Charleston, West Virginia 25304 | |
| Washington, District of Columbia | |
| Las Vegas, Nevada 89109 | |
| Sioux Falls, South Dakota |
