A Phase 2 Single Arm Study to Investigate the Safety and Clinical Activity of CAL-101 in Combination With Rituximab in Elderly Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This Phase 2 study will be the first time that CAL-101 is administered to previously
untreated patients with hematologic malignancies. CAL-101 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 CAL-101 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 CAL-101 in combination with rituximab in patients with CLL or SLL.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the overall response rate
Clinical activity will be evaluated using standard response definitions
every 2-3 months
No
Ronald Dubowy, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
101-08
NCT01203930
October 2010
March 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
The Universtity of Texas MD Anderson Cancer Center | Houston, Texas |