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NCT03112174 · ClinicalTrials.gov registry record · Phase 3
Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)
A Phase 3 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 366
- Enrollment target
NCT03112174: Completed Phase 3 study, sponsored by Pharmacyclics.
NCT03112174 is a Phase 3 study that has completed, run by Pharmacyclics. The registered enrollment target is 366 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03112174, a Phase 3 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 366 participants
- Enrollment target
Study 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.
Primary Outcome
TLS events are defined as follows: * Clinical TLS: any event that meets Howard criteria (N Engl J Med 2011;364:1844-1854) with the following exceptions: * For the purpose of TLS assessment during the Safety Run-in Period, only those increases in serum creatinine \> 1.0 mg/dL from pre-treatment baseline will be considered clinical TLS. * In participants with renal dysfunction at baseline (CrCl \< 60 mL/min), clinical TLS is defined as the presence of laboratory TLS plus either seizures, car
Interventions
- DRUG Venetoclax
- DRUG Ibrutinib
- DRUG Placebo Oral tablet to match Venetoclax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2017-06-19 |
| Est. Completion | 2024-06-27 |
| Phase | Phase 3 |
What the finished NCT03112174 record still lists
NCT03112174 is an interventional study that assigns participants to a tested intervention. The registered 366 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03112174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03112174 about?
NCT03112174 is a clinical study titled "Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)". 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.
What is the current status of trial NCT03112174?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 366 participants. The study started on 2017-06-19. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT03112174?
The interventions under investigation include: Venetoclax (DRUG), Ibrutinib (DRUG), Placebo Oral tablet to match Venetoclax (DRUG).
Who is sponsoring clinical trial NCT03112174?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03112174's enrollment target sits among peer trials
366 999th of 2000 higher than 1,000 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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