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NCT01578707 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase 3 study of Small Lymphocytic Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 391
- Enrollment target
- 20
- Study locations
NCT01578707: Completed Phase 3 study of Small Lymphocytic Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia, sponsored by Pharmacyclics.
NCT01578707 is a Phase 3 study of Small Lymphocytic Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia that has completed, run by Pharmacyclics. The registered enrollment target is 391 participants, above the 188-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01578707, a Phase 3 study of Small Lymphocytic Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 391 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Primary Outcome
The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.
Conditions Studied
Interventions
- DRUG ibrutinib
- DRUG ofatumumab
Study Locations (20)
California
- Site #408 - La Jolla
- Site #377 - Los Angeles
- Site #403 - Santa Maria
- Site #038 - Stanford
Massachusetts
- Site # 390 - Boston
- Site # 391 - Boston
- Site # 349 - Boston
New York
- Site # 350 - New Hyde Park
- Site # 200 - New York
- Site # 127 - Rochester
Ohio
- Site # 197 - Cincinnati
- Site # 217 - Columbus
Connecticut
- Site #411 - Norwalk
Georgia
- Site #107 - Marietta
Indiana
- Site # 379 - Evansville
Michigan
- Site # 130 - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2012-06 |
| Est. Completion | 2018-10-25 |
| Phase | Phase 3 |
What the finished NCT01578707 record still lists
NCT01578707 is an interventional study that assigns participants to a tested intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap, above the 188-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (108% higher).
The record links to 2 conditions, with Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which ibrutinib is the first listed.
NCT01578707 names 20 study sites across 12 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT01578707 about?
NCT01578707 is a clinical study titled "A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia". The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Ly...
What is the current status of trial NCT01578707?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 391 participants. The study started on 2012-06. Estimated completion is 2018-10-25.
What conditions does trial NCT01578707 study?
This clinical trial studies the following conditions: Small Lymphocytic Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia.
What interventions are being tested in trial NCT01578707?
The interventions under investigation include: ibrutinib (DRUG), ofatumumab (DRUG).
Who is sponsoring clinical trial NCT01578707?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01578707 being conducted?
This trial has 20 study locations across California, Connecticut, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Small Lymphocytic 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 NCT01578707's enrollment target sits among peer trials
391 14th of 81 higher than 68 of 81 other Small Lymphocytic Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Small Lymphocytic 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
-
A Long-term Extension Study of PCI-32765 (Ibrutinib)
RECRUITING · Phase 3
-
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
RECRUITING · Phase 3
-
Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study
RECRUITING · Phase 3
-
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
RECRUITING · Phase 3
-
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
RECRUITING · Phase 3
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