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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

Thank you

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:

No

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 CenterNew York, New York  10021
Medical College of WisconsinMilwaukee, Wisconsin  53226
Texas Oncology, P.A.Dallas, Texas  75246
Hackensack University Medical CenterHackensack, New Jersey  07601
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Rocky Mountain Cancer CenterDenver, Colorado  80218
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Florida Cancer SpecialistsFort Myers, Florida  33901
Stanford Cancer CenterStanford, California  94305-5824
Seattle Cancer Care AllianceSeattle, Washington  98109
Northwestern UniversityChicago, Illinois  60611
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
University of FloridaGainesville, Florida  32610-0277
Arizona Oncology AssociatesTucson, Arizona  85712-2254
M.D. Anderson Cancer CenterHouston, Texas  77030
Sarah Cannon Cancer CenterNashville, Tennessee  37203
UCLALos Angeles, California  90095
Hematology Oncology Associates of Northern New JerseyMorristown, New Jersey  07960
Georgetown University Medical Center Lombardi Cancer CenterWashington, District of Columbia  20007
Clearview Cancer InstituteHuntsville, Alabama  35805
Cancer Care Network of South TexasSan Antonio, Texas  78229
Ventura County Hematology Oncology SpecialistsOxnard, California  93030
Weill Cornell Medical CollegeNew York, New York  10021
Rocky Mountain Blood and Marrow Transplant ProgramDenver, Colorado  80218
Northwest Cancer Specialists, PCPortland, Oregon  97225
Yakima Valley Memorial Hospital / North Star LodgeYakima, Washington  98902
Virginia Cancer Specialists, PCFairfax, Virginia  22031
Collaborative Research Group LLCBoynton Beach, Florida  33435
Oncology and Hematology Associates of Southwest Virginia, IncRoanoke, Virginia  24014
University of California, San Diego- Moores Cancer CenterLa Jolla, California  92093