NCT03229200

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Pharmacyclics Switzerland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Leukemia, B-cell
• Graft Vs Host Disease
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Ibrutinib	Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Timeline

• Start date: 2017-05-22
• Primary completion: 2027-05-10
• Completion: 2027-05-10
• First posted: 2017-07-25
• Last updated: 2025-10-30

Locations

98 sites across 17 countries: United States, Australia, Canada, Czechia, France, Hungary, Italy, New Zealand, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study