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

Trial Information

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the
Efficacy and Safety of Idelalisib (GS-1101) in Combination with Rituximab for Previously
Treated Chronic Lymphocytic Leukemia.

Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to
receive either Idelalisib or placebo. All subjects will be administered rituximab. Subjects
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.

Inclusion Criteria

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

18 Months

Safety Issue:

Principal Investigator

Thomas Jahn, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-312-0116

NCT ID:

NCT01539512

Start Date:

February 2012

Completion Date:

December 2015

Related Keywords:

Chronic Lymphocytic Leukemia
CLL
CAL-101
GS 1101
PI3K
GS-US-312-0117
idelalisib
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid

Name	Location
Memorial Sloan Kettering Cancer Center	New York, New York 10021
Medical College of Wisconsin	Milwaukee, Wisconsin 53226
Texas Oncology, P.A.	Dallas, Texas 75246
Hackensack University Medical Center	Hackensack, New Jersey 07601
Long Island Jewish Medical Center	New Hyde Park, New York 11040
Rocky Mountain Cancer Center	Denver, Colorado 80218
Cancer Centers of the Carolinas	Greenville, South Carolina 29605
Florida Cancer Specialists	Fort Myers, Florida 33901
Stanford Cancer Center	Stanford, California 94305-5824
Seattle Cancer Care Alliance	Seattle, Washington 98109
Northwestern University	Chicago, Illinois 60611
Willamette Valley Cancer Center	Eugene, Oregon 97401-8122
University of Florida	Gainesville, Florida 32610-0277
Arizona Oncology Associates	Tucson, Arizona 85712-2254
M.D. Anderson Cancer Center	Houston, Texas 77030
Sarah Cannon Cancer Center	Nashville, Tennessee 37203
UCLA	Los Angeles, California 90095
Hematology Oncology Associates of Northern New Jersey	Morristown, New Jersey 07960
Georgetown University Medical Center Lombardi Cancer Center	Washington, District of Columbia 20007
Clearview Cancer Institute	Huntsville, Alabama 35805
Cancer Care Network of South Texas	San Antonio, Texas 78229
Ventura County Hematology Oncology Specialists	Oxnard, California 93030
Weill Cornell Medical College	New York, New York 10021
Rocky Mountain Blood and Marrow Transplant Program	Denver, Colorado 80218
Northwest Cancer Specialists, PC	Portland, Oregon 97225
Yakima Valley Memorial Hospital / North Star Lodge	Yakima, Washington 98902
Virginia Cancer Specialists, PC	Fairfax, Virginia 22031
Collaborative Research Group LLC	Boynton Beach, Florida 33435
Oncology and Hematology Associates of Southwest Virginia, Inc	Roanoke, Virginia 24014
University of California, San Diego- Moores Cancer Center	La Jolla, California 92093

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