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NCT02049515 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07
A Phase 3 study, sponsored by SecuraBio.
- Completed
- Registry status
- Phase 3
- Development phase
- 99
- Enrollment target
NCT02049515: Completed Phase 3 study, sponsored by SecuraBio.
NCT02049515 is a Phase 3 study that has completed, run by SecuraBio. The registered enrollment target is 99 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02049515, a Phase 3 study, has completed, sponsored by SecuraBio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 99 participants
- Enrollment target
Study Summary
A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or ofatumumab in study IPI-145-07 (NCT02004522).
Primary Outcome
ORR was defined as the percentage of participants with a best response (per investigator assessment) of complete response (CR), CR with incomplete marrow recovery (CRi), partial response (PR), or PR with lymphocytosis (PRwL), according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) or revised International Working Group Response (IWG) Criteria, with modification for treatment-related lymphocytosis. The 95% confidence interval was calculated using exact binomial method. Sel
Interventions
- DRUG Ofatumumab
- DRUG IPI-145
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2013-12 |
| Est. Completion | 2020-06-12 |
| Phase | Phase 3 |
What the finished NCT02049515 record still lists
NCT02049515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Ofatumumab is the first listed.
NCT02049515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02049515 about?
NCT02049515 is a clinical study titled "A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07". A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or ofatumumab in stud...
What is the current status of trial NCT02049515?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2013-12. Estimated completion is 2020-06-12.
What interventions are being tested in trial NCT02049515?
The interventions under investigation include: Ofatumumab (DRUG), IPI-145 (DRUG).
Who is sponsoring clinical trial NCT02049515?
This trial is sponsored by SecuraBio, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02049515's enrollment target sits among peer trials
99 1713th of 2000 higher than 287 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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