The primary objective of this study is to evaluate overall response rate (ORR) following treatment with idelalisib plus rituximab in participants with previously untreated chronic lymphocytic leukemia (CLL) with 17p deletion. 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
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
150 mg tablets administered orally twice daily
375 mg/m\^2 administered intravenously once weekly x 8 weeks
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Innovative Clinical Research Institute
Whittier, California, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, United States
The University of Chicago Medicine
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Overall Response Rate
Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).
Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.
Nodal Response Rate
Nodal response rate was 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.
Complete Response Rate
Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from first dose of study drug 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 IRC.
Overall Survival
Overall survival was defined as the interval from the start of study treatment to death from any cause.
Minimal Residual Disease Negativity Rate at Week 36
Minimal residual disease (MRD) negativity rate was 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 rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.
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Washington University School of Medicine
St Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
GHS Cancer Institute
Greenville, North Carolina, United States
Compass Oncology
Portland, Oregon, United States
Willamette Valley Cancer Center and Research Institute
Springfield, Oregon, United States
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