A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Public ClinicalTrials.gov record NCT01578707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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)
Study identification
- NCT ID
- NCT01578707
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 391 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2012 (Actual)
- Primary completion
- Nov 2013 (Actual)
- Completion
- Oct 25, 2018 (Actual)
- Last update posted
- Dec 18, 2019
2012 – 2018
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site #408 | La Jolla | California | 92093-0698 | — |
| Site #377 | Los Angeles | California | 90095 | — |
| Site #403 | Santa Maria | California | 93454 | — |
| Site #038 | Stanford | California | 94035 | — |
| Site #411 | Norwalk | Connecticut | 06856 | — |
| Site #107 | Marietta | Georgia | 30060 | — |
| Site # 379 | Evansville | Indiana | 47713 | — |
| Site # 390 | Boston | Massachusetts | 02114 | — |
| Site # 391 | Boston | Massachusetts | 02115 | — |
| Site # 349 | Boston | Massachusetts | 02215 | — |
| Site # 130 | Detroit | Michigan | 48201 | — |
| Site # 406 | Rochester | Minnesota | 55901 | — |
| Site # 059 | New Brunswick | New Jersey | 08903 | — |
| Site # 350 | New Hyde Park | New York | 11042 | — |
| Site # 200 | New York | New York | 10065 | — |
| Site # 127 | Rochester | New York | 14642-0001 | — |
| Site # 197 | Cincinnati | Ohio | 45291 | — |
| Site # 217 | Columbus | Ohio | 43210 | — |
| Site # 402 | Philadelphia | Pennsylvania | 19104 | — |
| Site # 396 | Greenville | South Carolina | 29601 | — |
| Site # 410 | Nashville | Tennessee | 37232-5505 | — |
| Site # 032 | Houston | Texas | 77030 | — |
| Site # 381 | Laredo | Texas | 78041 | — |
| Site # 210 | Charlottesville | Virginia | 22908 | — |
| Site # 404 | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01578707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 18, 2019 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01578707 live on ClinicalTrials.gov.