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

Gilead Sciences220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Chronic Lymphocytic Leukemia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion: * Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy * Require therapy for CLL * Have experienced CLL progression \< 24 months since the completion of the last prior therapy * Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.

Locations (72)

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

Outcomes

Primary Outcomes

Progression-Free Survival

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.

Time frame: Up to 17 months

Secondary Outcomes

Overall Response Rate

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.

Time frame: Up to 17 months

Lymph Node Response Rate

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.

Time frame: Up to 17 months

Overall Survival

Overall survival was defined as the interval from randomization to death from any cause.

Time frame: Up to 17 months

Complete Response Rate

Complete response rate was defined as the percentage of participants who achieved a complete response.

Time frame: Up to 17 months