Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
|ClinicalTrials.gov Identifier: NCT03229200|
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-cell Graft Vs Host Disease Solid Tumor||Drug: Ibrutinib||Phase 4|
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.|
|Actual Study Start Date :||May 22, 2017|
|Estimated Primary Completion Date :||July 2, 2027|
|Estimated Study Completion Date :||July 2, 2027|
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
- The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. [ Time Frame: The duration will be 3 years and will be re-evaluated. ]Assessment of percentage of patients rolling over from each parent study.
- Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [ Time Frame: Up to 3 years and will be re-evaluated. ]Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229200
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|Study Director:||Bernhard Hauns, MD||Pharmacyclics LLC.|