Clinical Trial: NCT03112174
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Pharmacyclics LLC. |
| Information Provided By: | Pharmacyclics LLC. |
| Last Update Posted: | 2025-07-22 |
Study Overview
Brief Summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Official Title
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Conditions
Mantle-Cell Lymphoma
Intervention / Treatment
- Drug: Ibrutinib
- Drug: Venetoclax
- Drug: Placebo Oral tablet to match Venetoclax
Other Study ID Numbers
- PCYC-1143-CA
- 2017-000129-12
- 2017
Start Date (Actual)
2017-06-19
Primary Completion Date (Actual)
2024-06-26
Study Completion Date (Actual)
2024-06-27
Enrollment (Actual)
366
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pharmacyclics LLC. |
| Information Provided By: | Pharmacyclics LLC. |
| Last Update Posted: | 2025-07-22 |
Study Overview
Brief Summary
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.
Official Title
Phase 3 Study of Ibrutinib in Combination With Venetoclax in Subjects With Mantle Cell Lymphoma
Conditions
Mantle-Cell Lymphoma
Intervention / Treatment
- Drug: Ibrutinib
- Drug: Venetoclax
- Drug: Placebo Oral tablet to match Venetoclax
Other Study ID Numbers
- PCYC-1143-CA
- 2017-000129-12
- 2017
Start Date (Actual)
2017-06-19
Primary Completion Date (Actual)
2024-06-26
Study Completion Date (Actual)
2024-06-27
Enrollment (Actual)
366
Study Type
Interventional
Phase
Phase 3