Phase 2 Study in Mantle Cell Lymphoma ACE-LY-004
Research type
Research Study
Full title
An Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma
IRAS ID
167922
Contact name
Martin Dyer
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-002117-28
Clinicaltrials.gov Identifier
118717, IND Number
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This is an open-label, phase 2 study of ACP-196 (study drug) in participants with Mantle Cell Lymphoma (MCL). Participants with MCL, who have relapsed (cancer has deteriorated) or failed to respond to their anticancer therapy will be given ACP-196. The purpose of the study is to find out if the study drug, given twice daily by mouth, will slow or stop their cancer from getting worse and whether the study drug has side effects.
Participants will be separated into 2 groups. One group will be those who have used bortezomib (cancer drug) in the past and one group will be those who have never used bortezomib.
ACP-196 is a type of drug that blocks proteins inside cells that help cells live and grow. The specific protein blocked by the study drug is believed to help blood cancer cells live and grow. It is possible that the study drug may kill the cancer cells or stop them from growing.
Approximately 117 participants will be enrolled in this study in approximately 30 sites across the United States, Europe and Asia Pacific.
The study consists of a screening visit (up to 21 days), treatment up to 24 cycles (each cycle is 28 days), Follow up (FU) within 30 days of last dose and Long Term FU (every 3 months).
The following assessments will be included:physical exam, vital signs (BP, pulse, breathing rate and temperature), weight, Eastern Cooperative Oncology Group (ECOG), Electrocardiogram (ECG), Blood and urine sampling, bone marrow biopsy
and aspirate sampling, Computerised Tomography (CT) scans and Positron Emission Tomography (PET) scans.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0135
Date of REC Opinion
6 May 2015
REC opinion
Further Information Favourable Opinion