Phase 3 N=220 Randomized Triple-blind Treatment

A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT01539512 ↗

Enrolled (actual)

220

Serious AEs

49.5%

Results posted

Oct 2014

Primary outcome: Primary: Progression-Free Survival — NA; 5.5 months — p=< 0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Idelalisib (Drug); Rituximab (Drug); Placebo to match idelalisib (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Oct 2013

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.