The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Idelalisib tablet administered orally
Rituximab administered intravenously
Bendamustine administered intravenously
Ofatumumab administered intravenously
Fludarabine administered orally
Everolimus administered orally twice daily until disease progression
Bortezomib administered as a subcutaneous injection
Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.
Lenalidomide administered orally
Clearview Cancer Institute
Huntsville, Alabama, United States
UCLA
Los Angeles, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Weill Medical College of Cornell
New York, New York, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer
Houston, Texas, United States
...and 1 more locations
Duration of Exposure to IDELA
Duration of exposure to IDELA was summarized using descriptive statistics.
Time frame: First dose date up to 12 months
Toxicity of Administration of IDELA
Percentage of participants experiencing toxicities of administration of IDELA were measured according to the Common Terminology Criteria for Adverse Events v4.02
Time frame: First dose date up to 5 years
Overall Response Rate
Overall Response Rate (ORR) was defined as the percentage of participants achieving a complete response (CR) or partial response (PR). The response definitions were based on the following standard criteria established for each indication: * CLL: International Workshop on chronic lymphocytic leukemia (IWCLL),2008 * iNHL \& MCL: Cheson, 2007
Time frame: Up to 5 years
Duration of Response
Duration of response (DOR) was defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression or death from any cause.
Time frame: Up to 5 years
Time to Response
Time to response (TTR) was defined as the interval from the start of study drug to the first documentation of CR or PR.
Time frame: Up to 5 years
Progression-free Survival
Progression free survival (PFS) was defined as the interval from the start of study drug to the earlier of the first documentation of disease progression or death from any cause. The response definitions were based on the following standard criteria established for each indication: * CLL: International Workshop on chronic lymphocytic leukemia (IWCLL), 2008 * iNHL \& MCL: Cheson, 2007
Time frame: Up to 5 years
Overall Survival
Overall Survival (OS) was defined as the interval from the start of study drug to death from any cause.
Time frame: Up to 5 years
Plasma Concentration of IDELA (Cohort 1, Cohorts 2 and 3, Cohort 5)
Time frame: Predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 0; predose, 1.5 hours postdose at Weeks 4, 12, and 24
Plasma Concentration of IDELA (Cohort 4)
Time frame: Predose at Week 0; predose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 hours postdose at Week 4; predose, 1.5 hours postdose at Week 12; and predose, 1.5 hours postdose at Week 24
Plasma Concentration of IDELA (Cohort 6)
Time frame: Predose, 1.5 hours postdose at Weeks 0, 4, 12 and 24
Plasma Concentration of IDELA (Cohort 7)
Time frame: Predose, 1.5 hours postdose at Weeks 0, 5 and 13
Sub-study: Plasma Concentration of IDELA (Cohorts 1-4)
Time frame: pre dose and 0.5, 1, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post dose
Plasma Concentration of Bendamustine
Time frame: Predose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 hours postdose at Week 0
Plasma Concentration of Everolimus
Time frame: Predose, 1.5 hours postdose at Weeks 0 and 4
Plasma Concentration of Lenalidomide
Time frame: Predose, 1.5 hours postdose at Week 1 and predose at Week 5
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