CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11 enrolled
Drug / intervention
Ibrutinibdrug
Likely dose
Ibrutinib 420 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02801578
NCT02801578Phase 3Completed
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A Pilot Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

M.D. Anderson Cancer Center·interventional·Posted Jun 16, 2016·Updated Feb 27, 2020

In Brief

A Phase 3 clinical trial evaluating Ibrutinib for Chronic Lymphocytic Leukemia. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Ibrutinib is currently FDA approved and commercially available for the treatment of CLL. However, some researchers think the approved dose may be unnecessarily high. The goal of this clinical research study is to compare 3 different daily doses of ibrutinib to learn how these doses affect the disease and your body. Researchers think that if a lower dose of ibrutinib can be found to be as effective as the currently approved dose this may help to lower the risk of side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 16, 2016
Enrollment StartJul 6, 2016
Primary CompletionJan 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.0 years ago

Interventions

Ibrutinibdrug

Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).