Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a randomized (individuals will be assigned by chance to study treatments),
double-blind (individuals and study personnel will not know the identity of study
treatments), placebo (an inactive substance that is compared with a drug to test whether the
drug has a real effect in a clinical trial)-controlled study to determine the benefits and
risks of combining ibrutinib and bendamustine and rituximab (BR) in patients with relapsed
or refractory CLL/SLL following at least 1 line of prior systemic therapy. Approximately 580
patients will be randomized in a 1:1 ratio to either treatment arm A (placebo) or treatment
arm B (ibrutinib 420 mg). Study medication will be administered orally once daily on a
continuous schedule. All patients will receive BR as the background therapy plus either
ibrutinib or placebo for a maximum of 6 cycles, after which treatment with ibrutinib or
placebo will continue until disease progression or unacceptable toxicity. A treatment cycle
will be defined as 28 days. The study will include a screening phase, a treatment phase, and
a follow-up phase. Study end is defined as when either 80% of the patients have died or 4
years after the last patient is randomized into the study, whichever occurs first. One
interim analysis is planned for the study. Efficacy evaluations will include computed
tomography scans, laboratory testing, focused physical examinations, bone marrow biopsy and
aspirate, and assessment of patient-reported outcomes. In both treatment arms, samples for
the development of a population-based pharmacokinetic (PK; study of what the body does to a
drug) approach will be collected. Safety will be assessed throughout the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression-free survival
Up to 4 years after the last patient is randomized
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100840
NCT01611090
September 2012
March 2018
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Albany, Georgia 31701 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
Little Rock, Arkansas 72205-7199 | |
Kansas City, Kansas 66160 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Albuquerque, New Mexico 87131-5636 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Eugene, Oregon | |
Indianapolis, Indiana | |
Charleston, South Carolina | |
Lebanon, New Hampshire | |
Tulsa, Oklahoma | |
Charleston, West Virginia 25304 | |
Washington, District of Columbia | |
Sioux Falls, South Dakota | |
Bismarck, North Dakota 58501 |