Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of Idelalisib Alone and in Combination With Rituximab in Elderly Subjects With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This study is to evaluate the safety and clinical activity of idelalisib alone and in
combination with rituximab in patients with CLL or SLL.
This Phase 2 study will be the first time that idelalisib is administered to previously
untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical
activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity,
which supports its evaluation in previously untreated patients. The study population is
limited to patients over 65 years of age because younger patients are generally appropriate
for standard immunochemotherapy regimens that are highly active. Since the mechanism of
action of idelalisib is distinct from rituximab, it is hypothesized that the combination will
be more active than either agent alone. This study will establish initial safety and clinical
activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of
this study will establish safety and clinical activity of idelalisib alone in subjects with
untreated CLL or SLL.
n/a
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