Pediatric Clinical Trials
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Idelalisib
- drug: Rituximab
- drug: Placebo to match idelalisib
Eligibility
Inclusion:
- Adult subjects with previously treated recurrent CLL who have measurable
lymphadenopathy
- Require therapy for CLL
- Have experienced CLL progression < 24 months since the completion of the last prior
therapy
- Currently not sufficiently fit to receive cytotoxic therapy because of
chemotherapy-induced bone marrow damage or comorbidities.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting