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.
To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
635
Administered orally (PO)
Administered intravenously (IV)
Administered intravenously (IV)
Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
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.
Time frame: Up to 6 years
Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
Time frame: Up to 6 years
Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.
Time frame: Up to 6 years
IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.
Time frame: Up to 6 years
Overall survival in Arm 1 compared to Arm 2
Defined as the time from randomization until the date of death from any cause.
Time frame: Up to 6 years
IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.
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Placebo comparator
Research Site
Tucson, Arizona, United States
Research Site
Downey, California, United States
Research Site
Santa Monica, California, United States
Research Site
New Haven, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Tallahassee, Florida, United States
Research Site
West Palm Beach, Florida, United States
Research Site
Marietta, Georgia, United States
Research Site
Westwood, Kansas, United States
Research Site
Louisville, Kentucky, United States
...and 218 more locations
Time frame: Up to 6 years
IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
Time frame: Up to 6 years