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NCT01611090 · ClinicalTrials.gov registry record · Phase 3
A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 578
- Enrollment target
NCT01611090: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01611090 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 578 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611090, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 578 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Primary Outcome
PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes \>1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); \>=50% increase in existing lymph nodes; \>=50% increase in enlargement of liver or spleen; \>=50% increase from baseline in lymphocyte coun
Interventions
- DRUG Placebo
- DRUG Rituximab
- DRUG Ibrutinib
- DRUG Bendamustine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2012-09-19 |
| Est. Completion | 2019-01-23 |
| Phase | Phase 3 |
What the finished NCT01611090 record still lists
NCT01611090 is an interventional study that assigns participants to a tested intervention. The registered 578 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 (25% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01611090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01611090 about?
NCT01611090 is a clinical study titled "A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
What is the current status of trial NCT01611090?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 578 participants. The study started on 2012-09-19. Estimated completion is 2019-01-23.
What interventions are being tested in trial NCT01611090?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Ibrutinib (DRUG), Bendamustine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01611090?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01611090's enrollment target sits among peer trials
578 661st of 2000 higher than 1,340 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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