A Phase 2/3 interventional study of Ibrutinib in Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by M.D. Anderson Cancer Center · Phase 2/3, Interventional, and Treatment
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 Drug Administration:
Each study cycle is 28 days.
If you are found to be eligible to take part in this study, you will take ibrutinib capsules by mouth every day for 3 cycles. Each dose of ibrutinib should be taken at about the same time, either with or without food.
During Cycle 1, you will receive the highest dose of ibrutinib (the dose that is currently FDA approved). You will take 3 capsules each day during Cycle 1. During Cycle 2, you will receive the second-highest dose and you will take 2 capsules each day. During Cycle 3, you will take the lowest dose of ibrutinib and you will take 1 capsule each day.
You must swallow the ibrutinib capsules whole without opening, breaking, or chewing them.
You will be given a study drug diary to keep track of each dose of ibrutinib taken, including the time the dose was taken, any missed or vomited doses and the reason for missing the dose, and any doses that you vomited.
Study Visits:
On Days 1, 8 and 28 of each cycle blood (about 1-2 tablespoons total) will be drawn before your dose of ibrutinib and then at 4 and 24 hours after your dose for pharmacodynamic (PD) and pharmacokinetic (PK) testing, to help researchers understand how ibrutinib works in the body, and to learn if the dose you are taking is as effective as other doses (Exception: there will be no 4-hour blood draw on day 28). PK testing measures the amount of study drug in the body at different time points. PD testing measures how the level of study drug in your body may affect the disease. You will need to return to the clinic on the following day (Days 2, 9 and 29 of each cycle [Day 1 of the next cycle]) for the last blood draw.
On Day 28 of each cycle:
Length of Study:
You may receive ibrutinib on this study for up to 3 cycles. After this time, you will continue treatment for CLL as directed by your doctor. This may or may not include ibrutinib. If you do continue to take ibrutinib after the study is over, your doctor will determine the best dose for you to be taking.
You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will be over after your last dose of ibrutinib (after the end of Cycle 3).
This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of CLL. It is considered investigational to compare 3 different doses of ibrutinib. The study doctor can explain how the study drug is designed to work.
Up to 12 participants will be enrolled in this study. All will take part at MD Anderson.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 11 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Ibrutinib
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).
Also known as: PCI-32765, Imbruvica
Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy
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.
Time frame: 3 cycles, up to 90 days
Recruitment Period: July 2016 to June 2017
| Milestone | Ibrutinib |
|---|---|
| Started | 11 |
| Completed | 9 |
| Not completed | 2 |
| Withdrew: Adverse event | 2 |
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.
| Participants | Ibrutinib |
|---|---|
| Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy | 8 |
Collected over Up to 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrutinib | 0/11 (0%) | 1/11 (9.1%) | 6/11 (54.5%) |
| Event | Ibrutinib |
|---|---|
| Surgical ProcedureSurgical and medical procedures | 1/11 |
| Event | Ibrutinib |
|---|---|
| DiarrheaGastrointestinal disorders | 3/11 |
| NauseaGastrointestinal disorders | 2/11 |
| Gastroesophageal Reflux DiseaseGastrointestinal disorders | 1/11 |
| BruisingInjury, poisoning and procedural complications | 1/11 |
| Rash AcneiformSkin and subcutaneous tissue disorders | 1/11 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/11 |
| VomitingGastrointestinal disorders | 1/11 |
| Dry SkinSkin and subcutaneous tissue disorders | 1/11 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/11 |
| Muscle weakness lower limbMusculoskeletal and connective tissue disorders | 1/11 |
| Age, Categorical(Participants) | Ibrutinib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 3 |
| Age, Continuous(years) | Ibrutinib |
|---|---|
| Median | 68 (52 to 79) |
| Sex: Female, Male(Participants) | Ibrutinib |
|---|---|
| Female | 6 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Ibrutinib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Ibrutinib |
|---|---|
| United States | 11 |
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center