Phase 3
Completed N=220
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT01539512 ↗Enrolled (actual)
220
Serious AEs
49.5%
Results posted
Oct 2014
Primary outcomePrimary: Progression-Free Survival — NA; 5.5 months — p=< 0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival |
NA; 5.5 | < 0.0001 sig |
| SECONDARY Overall Response Rate |
74.5; 14.5 | — |
| SECONDARY Lymph Node Response Rate |
92.2; 5.9 | — |
| SECONDARY Overall Survival |
NA; NA | — |
| SECONDARY Complete Response Rate |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01539512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.