A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Phase 3

Completed

Interventions: Drug: Rituximab
Drug: Idelalisib
Drug: Placebo to match idelalisib

Brief Summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo + rituximab	Rituximab	Participants will receive placebo to match idelalisib plus rituximab
Placebo + rituximab	Placebo to match idelalisib	Participants will receive placebo to match idelalisib plus rituximab
Idelalisib + rituximab	Idelalisib	Participants will receive idelalisib plus rituximab
Idelalisib + rituximab	Rituximab	Participants will receive idelalisib plus rituximab

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	Up to 17 months	Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 17 months	Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. Partial response was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
Lymph Node Response Rate	Up to 17 months	Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Overall Survival	Up to 17 months	Overall survival was defined as the interval from randomization to death from any cause.
Complete Response Rate	Up to 17 months	Complete response rate was defined as the percentage of participants who achieved a complete response.

Locations (71): Clearview Cancer Institute
🇺🇸
Huntsville, Alabama, United States
Arizona Oncology Associates
🇺🇸
Tucson, Arizona, United States
University of California, San Diego- Moores Cancer Center
🇺🇸
La Jolla, California, United States
Ventura County Hematology Oncology Specialists
🇺🇸
Oxnard, California, United States
UCLA
🇺🇸
Santa Monica, California, United States
Stanford Cancer Center
🇺🇸
Stanford, California, United States
Rocky Mountain Blood and Marrow Transplant Program
🇺🇸
Denver, Colorado, United States
Rocky Mountain Cancer Center
🇺🇸
Denver, Colorado, United States
Georgetown University Medical Center Lombardi Cancer Center
🇺🇸
Washington, District of Columbia, United States
Collaborative Medical Research Corporation
🇺🇸
Boynton Beach, Florida, United States
Scroll for more (61 remaining)
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States