A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
Stopped early · Phase 2
Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
In brief
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.
Key facts
- Study ID
- NCT01203930
- Run by
- Gilead Sciences
- People needed
- 105
- Starts
- 2010-10-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2018-11-16
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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