An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

Running, not enrolling · Phase 2

Conditions studied: Mantle Cell Lymphoma (MCL)

In brief

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).

Key facts

Study ID

NCT02213926

Run by

Acerta Pharma BV

People needed

124

Starts

2015-03-02

Expected to finish

2026-09-06

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Chicago, Illinois, United States
• Research Site — Niles, Illinois, United States
• Research Site — Peoria, Illinois, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Seattle, Washington, United States
• 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 — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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