Spots Global Cancer Trial Database for A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
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Trial Identification
Brief Title: A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
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
Study ID: NCT01203930
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Diego, Moores Cancer Center, La Jolla, California, United States
Stanford University School of Medicine, Stanford, California, United States
Columbia University - Herbert Irving Pavilion, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The Universtity of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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