A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lymphoma, Mantle Cell

In brief

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.

Key facts

Study ID: NCT02972840
Run by: Acerta Pharma BV
People needed: 635
Starts: 2017-04-05
Expected to finish: 2027-02-15
Last updated by the study team: 2026-06-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 .

You may not qualify if…

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.

Where it is running

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
Research Site — Ann Arbor, Michigan, United States
Research Site — Rochester, Minnesota, United States
Research Site — Kansas City, Missouri, United States
Research Site — St Louis, Missouri, United States
Research Site — Hackensack, New Jersey, United States
Research Site — Morristown, New Jersey, United States
Research Site — Hawthorne, New York, United States
Research Site — Lake Success, New York, United States
Research Site — Portland, Oregon, United States
Research Site — Charleston, South Carolina, United States
Research Site — Greenville, South Carolina, United States
Research Site — Chattanooga, Tennessee, United States
Research Site — Nashville, Tennessee, United States
Research Site — Houston, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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