Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatments idelalisib, rituximab, bendamustine, placebo to match idelalisib
Phase phase 3
Targets CD20, PI3K
Sponsor Gilead Sciences
Start date June 2012
End date June 2015
Trial size 416 participants
Trial identifier NCT01569295, 2011-006292-20, GS-US-312-0115

Summary

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Participants will receive idelalisib plus bendamustine and rituximab for up to 30 months.
idelalisib GS-1101
Idelalisib 150 mg administered orally twice daily
rituximab Rituxan®
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
bendamustine Ribomustin
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
(Placebo Comparator)
Participants will receive placebo to match idelalisib plus bendamustine and rituximab for up to 30 months.
rituximab Rituxan®
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
bendamustine Ribomustin
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
placebo to match idelalisib
Placebo to match idelalisib administered orally twice daily

Primary Outcomes

Measure
Progression-Free Survival
time frame: Up to 30 months

Secondary Outcomes

Measure
Overall Response Rate
time frame: Up to 30 months
Lymph Node Response Rate
time frame: Up to 30 months
Overall Survival
time frame: Up to 30 months
Complete Response Rate
time frame: Up to 30 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Previously treated recurrent CLL - Measurable lymphadenopathy - Requires therapy for CLL - Has experienced CLL progression <36 months since the completion of the last prior therapy Exclusion Criteria: - Recent history of a major non-CLL malignancy - Evidence of an ongoing infection - CLL refractory to bendamustine - Concurrent participation in another therapeutic clinical trial

Additional Information

Official title A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.