Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
NCT03229200 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 297
Last updated 2025-10-30
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.
Conditions
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Leukemia, B-cell
- Graft Vs Host Disease
- Solid Tumor
Interventions
- DRUG
-
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Sponsors & Collaborators
-
Janssen Biotech, Inc., including Johnson & Johnson
collaborator UNKNOWN -
Pharmacyclics Switzerland GmbH
lead INDUSTRY
Principal Investigators
-
Kevin Wu · AbbVie
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-22
- Primary Completion
- 2027-05-10
- Completion
- 2027-05-10
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Czechia
- France
- Hungary
- Italy
- New Zealand
- Poland
- Russia
- South Korea
- Spain
- Sweden
- Taiwan
- Turkey (Türkiye)
- Ukraine
- United Kingdom
Study Locations
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