An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
This trial is active, not recruiting.
|Condition||mantle cell lymphoma (mcl)|
|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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
ACP-196 (acalabrutinib) Regimen 1
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
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
|Official title||An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma|
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