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NCT01722487 · ClinicalTrials.gov registry record · Phase 3
Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL
A Phase 3 study, sponsored by Pharmacyclics.
- Completed
- Registry status
- Phase 3
- Development phase
- 269
- Enrollment target
NCT01722487: Completed Phase 3 study, sponsored by Pharmacyclics.
NCT01722487 is a Phase 3 study that has completed, run by Pharmacyclics. The registered enrollment target is 269 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722487, a Phase 3 study, has completed, sponsored by Pharmacyclics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 269 participants
- Enrollment target
Study Summary
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Primary Outcome
The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS Progressive disease according to 2008 IWCLL guidelines was defined as: * Group A * Lymphadenopathy, increase ≥50% * Hepatomegaly, increase ≥50% * Splenomegaly, increase ≥50% * Blood lymphocytes, increase ≥ 50% over baseline * Group B * Platelets counts, decrease of ≥ 50% from baseline secondary to CLL * Hemoglob
Interventions
- DRUG Ibrutinib
- DRUG Chlorambucil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 269 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT01722487 record still lists
NCT01722487 is an interventional study that assigns participants to a tested intervention. The registered 269 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Ibrutinib is the first listed.
NCT01722487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01722487 about?
NCT01722487 is a clinical study titled "Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL". A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
What is the current status of trial NCT01722487?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 269 participants. The study started on 2013-03. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01722487?
The interventions under investigation include: Ibrutinib (DRUG), Chlorambucil (DRUG).
Who is sponsoring clinical trial NCT01722487?
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 NCT01722487's enrollment target sits among peer trials
269 1220th of 2000 higher than 779 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
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