A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02801578
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jul 6, 2016
Status verified
Feb 2020
Primary completion
Jan 28, 2019
Completion
Jan 28, 2019

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib
    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.

Primary Outcome Measure

Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy [ Time Frame: 3 cycles, up to 90 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies