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NCT02264574 · ClinicalTrials.gov registry record · Phase 3
A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
A Phase 3 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 229
- Enrollment target
NCT02264574 is a Phase 3 study that has completed, run by Pharmacyclics. The registered enrollment target is 229 participants.
The verdict
NCT02264574, a Phase 3 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 229 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.
Interventions
- DRUG Obinutuzumab
- DRUG Ibrutinib
- DRUG Chlorambucil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2014-10-06 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02264574
The ClinicalTrials.gov registry entry for NCT02264574 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacyclics, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT02264574 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02264574 about?
NCT02264574 is a clinical study titled "A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)". The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according ...
What is the current status of trial NCT02264574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 229 participants. The study started on 2014-10-06. Estimated completion is 2019-09-03.
What interventions are being tested in trial NCT02264574?
The interventions under investigation include: Obinutuzumab (DRUG), Ibrutinib (DRUG), Chlorambucil (DRUG).
Who is sponsoring clinical trial NCT02264574?
This trial is sponsored by Pharmacyclics, which has 54 total clinical trials registered on ClinicalTrials.gov.
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