Extended Access to Ibrutinib for Patients Benefiting from Treatment
Sponsor: Pharmacyclics Switzerland GmbH
ClinicalTrials ID:NCT03229200
This study allows patients who have completed previous ibrutinib trials and are still benefiting from the treatment to continue receiving ibrutinib, especially if they cannot access it commercially in their area.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is designed to provide ongoing access to the medication ibrutinib for patients who have finished earlier ibrutinib studies and are still seeing positive results. It is especially for those who cannot get ibrutinib through regular channels in their region. Patients will continue taking ibrutinib at the same dose they were on in their previous study, as long as they keep benefiting from it and until it becomes available commercially for their condition.
Description
Patients who join this study will keep taking ibrutinib by mouth at the same dose and schedule they were on in their previous study. They can continue as long as they are benefiting from the treatment and until ibrutinib is available for their condition in their area. Regular health checks will be done according to local standards for the disease studied in the previous trial. At each visit, any ongoing or new side effects, serious health issues, pregnancy events, other cancers, and special situations will be recorded.
Eligibility Criteria
Inclusion Criteria
- Must have been part of a previous ibrutinib study and still benefit from the treatment, according to their doctor.
- Cannot access ibrutinib commercially in their area.
- Must have completed all assessments in their previous study and wish to continue treatment.
- Must sign a consent form to continue treatment.
- Must agree to use effective birth control during treatment and for 90 days after the last dose.
Exclusion Criteria
- Must not meet any conditions from the previous study that require stopping ibrutinib.
- Must not have any condition that would interfere with participating in the study, according to their doctor.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after the last dose cannot participate.
- Men planning to father a child during the study or within 90 days after the last dose cannot participate.
- Must be willing and able to participate in all required evaluations and procedures.
- Must understand the study and sign a consent form.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center | 91505 | Burbank | California |
| City Of Hope National Medical Center | 91010 | Duarte | California |
| UCSD Moores Cancer Center | 92093-0698 | La Jolla | California |
| University of California Los Angeles (UCLA) | 90095 | Los Angeles | California |
| Stanford University | 94305 | Stanford | California |
| Emory University | 30322 | Atlanta | Georgia |
| Northwestern University | 60611 | Chicago | Illinois |
| University of Chicago | 60637 | Chicago | Illinois |
| Norton Medical Plaza II, 3991 Dutchmans Lane | 40207 | Louisville | Kentucky |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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