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NCT01776840 · ClinicalTrials.gov registry record · Phase 3
A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma
A Phase 3 study of Mantle Cell Lymphoma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 523
- Enrollment target
- 20
- Study locations
NCT01776840: Completed Phase 3 study of Mantle Cell Lymphoma, sponsored by Janssen Research & Development.
NCT01776840 is a Phase 3 study of Mantle Cell Lymphoma that has completed, run by Janssen Research & Development. The registered enrollment target is 523 participants, above the 99-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (428% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01776840, a Phase 3 study of Mantle Cell Lymphoma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 523 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.
Primary Outcome
Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD criteria: Appearance of new nodal lesion 1.5 centimeters \[cm\] in any axis, 50% increa
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Ibrutinib
- DRUG Bendamustine
Study Locations (20)
Illinois
- - Chicago
- - Maywood
- - Niles
- - Springfield
California
- - Burbank
- - La Jolla
- - Stanford
Connecticut
- - New Haven
- - Stamford
Iowa
- - Iowa City
- - Sioux City
Kansas
- - Topeka
- - Westwood
Kentucky
- - Lexington
- - Louisville
Arizona
- - Tucson
Colorado
- - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2013-05-16 |
| Est. Completion | 2024-06-24 |
| Phase | Phase 3 |
What the finished NCT01776840 record still lists
NCT01776840 is an interventional study that assigns participants to a tested intervention. The registered 523 participants enrollment target is mid-sized for trials with a published cap, above the 99-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (428% higher).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01776840 names 20 study sites across 11 states, led by Illinois, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01776840 about?
NCT01776840 is a clinical study titled "A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma". The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.
What is the current status of trial NCT01776840?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 523 participants. The study started on 2013-05-16. Estimated completion is 2024-06-24.
What conditions does trial NCT01776840 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT01776840?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Ibrutinib (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01776840?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01776840 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01776840's enrollment target sits among peer trials
523 4th of 102 higher than 99 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Long-term Extension Study of PCI-32765 (Ibrutinib)
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COMPLETED · Phase 3
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