This trial is active, not recruiting.

Condition mantle cell lymphoma (mcl)
Treatment acp-196 (acalabrutinib)
Phase phase 2
Target BTK
Sponsor Acerta Pharma BV
Start date September 2014
End date March 2017
Trial size 124 participants
Trial identifier NCT02213926, ACE-LY-004


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
ACP-196 (acalabrutinib) Regimen 1
acp-196 (acalabrutinib)

Primary Outcomes

Overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with previously treated MCL.
time frame: Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.