For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Men and women ≥ 18 years of age.
  2. Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  4. 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

  1. 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
  2. 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.
  3. 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.
  4. Breast feeding or pregnant
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1 650 591 4024Email iconEmail Study Center

Study’s details


Contition

Mantle Cell Lymphoma (MCL)

Age

18+

Phase

Phase 2

Participants needed

124

Est. Completion Date

Dec 2025

Treatment type

Interventional


Sponsor

Acerta Pharma BV

ClinicalTrials.gov identifier

NCT02213926

Study number

ACE-LY-004

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