Study of ACP-196 Versus Ibrutinib in previously treated CLL patients
Research type
Research Study
Full title
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
IRAS ID
181246
Contact name
Anita Sarma
Contact email
Sponsor organisation
Acerta Pharma BV
Eudract number
2014-005530-64
Duration of Study in the UK
3 years, 9 months, 1 days
Research summary
Chronic Lymphocytic Leukaemia (CLL) is a cancer of B cells (a type of white blood cell) that predominantly affects the elderly population.
Chemoimmunotherapy has become a standard for the treatment of young and/or fit individuals with CLL who require treatment. However, elderly subjects and those with
pre -exisiting diseases are often unable to tolerate combination chemoimmunotherapy regimens, or experience inferior outcomes. Ibrutinib, a type of orally administered drug called a Btk inhibitor, was recently approved for certain groups of patients with CLL and has shown favourable outcomes for these patients. ACP-196 has recently been identified and is also an orally administered Btk inhibitor but inhibits more selectively than Ibrubtinib
ACP-196 has been well tolerated in healthy volunteers and patients with CLL and has shown sustained improvement in symptoms of CLL.
This study, sponsored by Acerta Pharma, will investigate if ACP-196 is as effective as Inbrutinib and if it is safe. 500 patients over the age of 18 will take part over 100 sites globally with approximately 7 hospitals in the UK. Half the patients will receive Inbrutinib and half will receive ACP-196. Patients will be randomised (by chance) to the study treatment and will know which treatment they are receiving.
Each patient will give informed consent and will be screened for suitability and will be in the study for approximately 4 years unless early withdrawal is necessary. Patients will visit their study doctor every week for 9 weeks and then every 12 weeks and will undergo tests per the schedule in the study protocol such as physical examinations, vital signs, complete diaries and questionaires, blood tests for safety and effectiveness of study drugs, CT scans and ECG.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0492
Date of REC Opinion
31 Jul 2015
REC opinion
Further Information Favourable Opinion