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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01578707
The ClinicalTrials.gov registry entry for NCT01578707 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 391 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 188-participant average among 81 other Small Lymphocytic Lymphoma trials with a reported enrollment target (108% higher). The listed sponsor is Pharmacyclics, which has 54 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.