Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Pharmacyclics.
NCT02264574 is a Phase 3 study that has completed, run by Pharmacyclics. The registered enrollment target is 229 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as time from the date randomization to the date of first IRC-confirmed disease progression (PD) or date of death due to any cause, whichever occurred first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of PD was conducted in accordance with the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Halleck et al) with the modification that treatment-related lymphocytosis in the absence of other signs
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 |
What the finished NCT02264574 record still lists
NCT02264574 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT02264574 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02264574's enrollment target sits among peer trials
229 1309th of 2000 higher than 692 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02710253 · 230 participants · Phase 2
Salvage Radiation Therapy in Treating Patients With Metastatic Cancer That Has Progressed After Systemic Immunotherapy
- NCT02777879 · 230 participants
Lung Microbiome and Inflammation in Early COPD
- NCT03824483 · 230 participants · Phase 2
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
- NCT03833622 · 230 participants · NA
Shared Decision Making to Improve Goals of Care in the ED
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI