The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria:
* Men and women ≥ 18 years of age.
* Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion criteria:
* A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196 (acalabrutinib), or put the study outcomes at undue risk
* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, 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.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
* Breast feeding or pregnant
Primary outcome measure(s)
Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. — From the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.
Trial sites (58)
Facility
City
Region
Status
Research Site
Tampa
Florida
Research Site
Chicago
Illinois
Research Site
Niles
Illinois
Research Site
Peoria
Illinois
Research Site
Boston
Massachusetts
Research Site
Hackensack
New Jersey
Research Site
New York
New York
Research Site
Houston
Texas
Research Site
Seattle
Washington
Research Site
Monash
Australia
Research Site
Sydney
Australia
Research Site
Wodonga
Australia
Research Site
Bruges
Belgium
Research Site
Brussels
Belgium
Research Site
Brussels
Belgium
Research Site
Liège
Belgium
Research Site
Yvoir
Belgium
Research Site
Prague
Czechia
Research Site
Angers
France
Research Site
Caen
France
Research Site
Clermond Ferrand
France
Research Site
Créteil
France
Research Site
Dijon
France
Research Site
Grenoble
France
Research Site
La Roche - Sure-Yon
France
Research Site
Lille
France
Research Site
Montpellier
France
Research Site
Nantes
France
Research Site
Paris
France
Research Site
Paris
France
Research Site
Pessac
France
Research Site
Pierre-Bénite
France
Research Site
Rennes
France
Research Site
Rouen
France
Research Site
Saint-Priest-en-Jarez
France
Research Site
Strasbourg
France
Research Site
Toulouse
France
Research Site
Tours
France
Research Site
Vandœuvre-lès-Nancy
France
Research Site
Bologna
Italy
+ 18 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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