A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.
Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.
Continuous dosing with study drug at the designated cohort dose level up to Month 6. At the end of combination treatment, ABT-199 monotherapy may continue for up to 2 years following the date of the last subject enrolled.
Elisa Cerri, MD
United States: Food and Drug Administration
|Site Reference ID/Investigator# 70398||La Jolla, California 92093-0698|
|Site Reference ID/Investigator# 71593||Chicago, Illinois 60611|
|Site Reference ID/Investigator# 71813||New Hyde Park, New York 11042|
|Site Reference ID/Investigator# 71393||Durham, North Carolina 27710|