A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)
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|ClinicalTrials.gov Identifier: NCT02801578|
Recruitment Status : Completed
First Posted : June 16, 2016
Last Update Posted : May 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Ibrutinib||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)|
|Actual Study Start Date :||July 6, 2016|
|Actual Primary Completion Date :||January 28, 2019|
|Actual Study Completion Date :||January 28, 2019|
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
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).
- Change in Bruton's Tyrosine Kinase (BTK) Occupancy in Different Daily Doses of Ibrutinib in Participants with Chronic Lymphocytic Leukemia (CLL) [ Time Frame: Just before dosing and at 4 and 24 hours post-dosing on Days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle ]
Participants receive three 28 day cycles with decreasing dose levels.
BTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801578
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Prithviraj Bose, MD||M.D. Anderson Cancer Center|