This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Men and women, ≥ 65 years of age.
* Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
* MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .
Exclusion Criteria:
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
* Concurrent participation in another therapeutic clinical trial.
Primary outcome measure(s)
Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2 — Up to 6 years Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
Trial sites (228)
Facility
City
Region
Status
Research Site
Tucson
Arizona
Research Site
Downey
California
Research Site
Santa Monica
California
Research Site
New Haven
Connecticut
Research Site
Washington D.C.
District of Columbia
Research Site
Tallahassee
Florida
Research Site
West Palm Beach
Florida
Research Site
Marietta
Georgia
Research Site
Westwood
Kansas
Research Site
Louisville
Kentucky
Research Site
Ann Arbor
Michigan
Research Site
Rochester
Minnesota
Research Site
Kansas City
Missouri
Research Site
St Louis
Missouri
Research Site
Hackensack
New Jersey
Research Site
Morristown
New Jersey
Research Site
Hawthorne
New York
Research Site
Lake Success
New York
Research Site
Portland
Oregon
Research Site
Charleston
South Carolina
Research Site
Greenville
South Carolina
Research Site
Chattanooga
Tennessee
Research Site
Nashville
Tennessee
Research Site
Houston
Texas
Research Site
San Antonio
Texas
Research Site
Tyler
Texas
Research Site
Charlottesville
Virginia
Research Site
Fort Belvoir
Virginia
Research Site
Seattle
Washington
Research Site
Seattle
Washington
Research Site
Seattle
Washington
Research Site
Morgantown
West Virginia
Research Site
Buenos Aires
Argentina
Research Site
Buenos Aires
Argentina
Research Site
Buenos Aires
Argentina
Research Site
Buenos Aires
Argentina
Research Site
Caba
Argentina
Research Site
Córdoba
Argentina
Research Site
Bedford Park
Australia
Research Site
Concord
Australia
+ 188 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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