ACE-CL-208
Research type
Research Study
Full title
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
IRAS ID
198679
Contact name
Peter Hillmen
Contact email
Sponsor organisation
Acerta Pharma, BV
Eudract number
2015-005317-68
Duration of Study in the UK
3 years, 8 months, 0 days
Research summary
Relapsed/refractory chronic lymphocytic leukemia (CLL) is a type of blood cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell).
ACP-196 (acalabrutinib) is a type of drug that blocks proteins inside cells that help cells live and grow. The purposes of this study is to find out if the study drug will slow or stop cancer from getting worse and whether it causes side effects.
Approximately 80 participants will take part in this study at about 50 study centers globally.
ACP-196 is an oral capsule. Each capsule is 100mg and will be administered to all participants twice a day. Patients will come to the study center approximately 24 times during the study. Tests will be conducted by the doctor during this time to monitor health, including physical examinations, blood/urine samples, CT or MRI and bone scans.
The Screening period can take up to 30 days and patients will have 1 visit to the clinic and a CT (computed tomography) scan. A single course or cycle of the study drug is 28 days. In the first two months (Cycle 1 through Cycle 2), participants will visit the clinic every 2 weeks. At Cycle 3 through Cycle 6 patients will visit the clinic once a month. Thereafter (beginning at Cycle 9), patients will visit the clinic every 3 months. If participants complete all the planned visits, there will be a follow-up visit thirty days (30) after last dose of the study drug. If at the time of the 30-day follow-up visit disease has not progressed or patients will not start another treatment for their disease, they may be followed every 3 months with a CT scan until their disease progresses or they start another treatment.
A pharmaceutical company is funding this research.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
16/YH/0113
Date of REC Opinion
16 May 2016
REC opinion
Further Information Favourable Opinion