This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
* A1a) acalabrutinib, dose A daily: biopsy (T) schedule W; * A1b) acalabrutinib, dose A daily: biopsy (T) schedule V. * A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y; * A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
B1c) acalabrutinib, dose A daily: biopsy (U) schedule W; • B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.
Research Site
Bethesda, Maryland, United States
Response Based on Overall Response Rate
The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.
Time frame: Cycle 1 (28 Days) to 6 months
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