Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatments idelalisib, ofatumumab
Phase phase 3
Target PI3K
Sponsor Gilead Sciences
Start date December 2012
End date January 2015
Trial size 261 participants
Trial identifier NCT01659021, 2012-001236-65, GS-US-312-0119

Summary

This study will evaluate the effect of the addition of idelalisib (GS-1101) to ofatumumab on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab (300 mg on Day 1, followed by 1000 mg weekly for 8 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until definitive progression of CLL or protocol-specified study withdrawal
idelalisib Zydelig®
Idelalisib 150 mg tablets administered orally twice daily
ofatumumab Arzerra®
Ofatumumab administered intravenously
(Active Comparator)
Randomized Initial Therapy (24 weeks): Ofatumumab (300 mg on Day 1, followed by 2000 mg weekly for 8 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until definitive progression of CLL or protocol-specified study withdrawal
ofatumumab Arzerra®
Ofatumumab administered intravenously

Primary Outcomes

Measure
Progression-free survival
time frame: Up to 4 years

Secondary Outcomes

Measure
Overall response rate
time frame: Up to 4 years
Lymphadenopathy response rate
time frame: Up to 4 years
Overall survival
time frame: Up to 9 years
Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation
time frame: Up to 4 years
Complete response rate
time frame: Up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Adults 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 - Have disease that is not refractory to ofatumumab Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

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