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

Protocol: 
AAAQ4711
Phase: 
III

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

The purpose of this study, which involves research, is to determine if an experimental drug: ACP- 196 is safe and effective in the treatment of this disease. The study program will be performed at about 108 clinics (sites) globally. It is expected that approximately 500 subjects will be enrolled in this study, divided into two groups.ACP-196 is an investigational drug, which means that it is still being tested in people and has not been approved by government agencies in any countries. ACP-196 has been tested previously in approximately 242 humans and has been well tolerated. ACP-196 is administered as an oral capsule. Ibrutinib (IMBRUVICA®) is already approved by government agencies in the United States and Europe as a treatment for patients with CLL and will be used as the comparator drug. Many patients have received ibrutinib for treatment of CLL. It is administered as an oral capsule.Patients will be randomly assigned to either ACP-196 or ibrutinib; the chances of receiving either type of treatment are a 50-50 chance (like the flip of a coin).

Are you Eligible? (Inclusion Criteria)

1) Diagnosis of CLL that meets published diagnostic criteria
(Hallek 2008):
- Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing >= 1 B-cell marker (CD19, CD20, or CD23) and CD5.
- Prolymphocytes may comprise <= 55% of blood lymphocytes.
- No evidence of cyclin D1 rearrangement or BCL-1 over expression.

2) Must have >= 1 of the following high-risk prognostic factors:
- Presence of 17p del by central laboratory
- Presence of 11q del by central laboratory

3) Must have received >= 1 prior therapies for CLL.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States