Lymphoma, Mantle Cell
Conditions
Interventions
investigational material(s)
Generic name etc : Acalabrutinib in combination with bendamustine and rituximab
INN of investigational material :
Therapeutic category code : 42- Antineoplastic agents
Dos
cycles are repeated every 28 days.
control material(s)
Generic name etc : Placebo in combination with bendamustine and rituximab
INN of investigational material :
Therapeutic category code : --- Oth
cycles are repeated every 28 days.
Sponsors
Acerta Pharma BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Pathologically confirmed MCL, with documentation of monoclonal CD20+ B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1. -MCL requiring treatment and for which no prior systemic anticancer therapies have been received. -Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. -Agreement to use highly effective forms of contraception during the study and 90 days after the last dose of acalabrutinib, 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is progression-free survival (PFS) as assessed by Independent Review Committee (IRC) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL). The primary analysis is a comparison of PFS between Arm 1 (acalabrutinib plus bendamustine and rituximab (BR)) and Arm 2 (placebo plus BR). | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Mexico, New Zealand, Peru, Poland, Romania, Russian Federation, South Korea, Spain, Taiwan, Ukraine, United States, Vietnam
Outcome results
None listed