The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
150 mg tablet administered orally twice daily
2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
Sansum Clinic
Santa Barbara, California, United States
UCLA Jonsson Comprehensive Cancer Center
Santa Monica, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
St Vincent Hospital, Sydney
Darlinghurst, New South Wales, Australia
UZ Ghent- hematology
Ghent, Belgium
Royal Victoria Regional Health Centre - Simcoe Musk
Barrie, Ontario, Canada
Centre Hospitalier du Mans
Le Mans, France
...and 8 more locations
Progression-Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Time frame: Up to 11 months
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
Time frame: Up to 11 months
Nodal Response Rate
Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.
Time frame: Up to 11 months
Complete Response Rate
Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Time frame: Up to 11 months
Overall Survival
Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Time frame: Up to 11 months
Minimal Residual Disease Negativity Rate at Week 36
Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.
Time frame: Up to 11 months
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