This study will assess the efficacy, safety and pharmacodynamic markers of the study drug, A6, in patients with CLL and small lymphocytic lymphoma (SLL).
In patients diagnosed with CLL or SLL, study medication will be injected subcutaneously two times a day in an outpatient setting for up to 6 cycles (28 days = 1 cycle) prior to the primary endpoint assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
Moores Cancer Center, UCSD
La Jolla, California, United States
Overall response rate
International Workshop on Chronic Lymphocytic Lymphoma (IWCLL) Guidelines for response of clinical, hematological, and bone marrow features.
Time frame: Assessed at Day 28 of Cycle 6
Safety of A6
Nature and frequency of adverse events
Time frame: Throughout 6 Cycles (6 months)
Determine IWCLL response rate in the Intent-To-Treat Population
Time frame: Throughout 6 Cycles (6 months)
Determine the response in patients who received all 6 cycles of A6
Time frame: 6 months
Determine progression-free survival
Time frame: Throughout 6 Cycles (6 months)
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