Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01980888
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.
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 this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 311
- Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
- No prior therapy for CLL other than corticosteroids for disease complications
- CLL that warrants treatment
- Presence of measurable lymphadenopathy
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key
- Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
- Known presence of myelodysplastic syndrome
- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
- Ongoing liver injury
- History of non-infectious pneumonitis
- Ongoing inflammatory bowel disease
- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
- Ongoing immunosuppressive therapy other than corticosteroids
- Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo+bendamustine+rituximab Rituximab Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. Idelalisib+bendamustine+rituximab Bendamustine Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. Placebo+bendamustine+rituximab Placebo Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. Idelalisib+bendamustine+rituximab Idelalisib Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. Placebo+bendamustine+rituximab Bendamustine Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks. Idelalisib+bendamustine+rituximab Rituximab Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
- Primary Outcome Measures
Name Time Method Progression-Free Survival Up to 22 months 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).
- Secondary Outcome Measures
Name Time Method Overall Response Rate Up to 22 months 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.
Minimal Residual Disease Negativity Rate at Week 36 Up to 22 months 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 or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.
Overall Survival Up to 22 months Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Nodal Response Rate Up to 22 months 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.
Complete Response Rate Up to 22 months 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.
Trial Locations
- Locations (90)
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Central Coast Medical Oncology
🇺🇸Santa Maria, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Memorial Healthcare System
🇺🇸Hollywood, Florida, United States
Cancer Specialists of North Florida
🇺🇸Jacksonville, Florida, United States
Florida Cancer Specialists-South
🇺🇸Sarasota, Florida, United States
Franciscan Physician Network Oncology & Hematology
🇺🇸Indianapolis, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Scroll for more (80 remaining)St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center🇺🇸Fullerton, California, United States