A Study of Bendamustine and Rituximab Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated Mantle Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:65 - Any
Updated:2/14/2019
Start Date:February 1, 2017
End Date:April 2023
Contact:Call Center
Email:Acertamc@dlss.com
Phone:1-888-292-9613

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma

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.


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.
We found this trial at
34
sites
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
?
mi
from
Hawthorne, NY
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
McAllen, TX
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
Overland Park, Kansas 66209
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
?
mi
from
Westwood, KS
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials