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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 Bendamustine and 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 Bendamustine and 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 Bendamustine and 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 bendamustine and
rituximab.

Inclusion Criteria


Inclusion:

- Previously treated recurrent CLL

- Measurable lymphadenopathy

- Requires therapy for CLL

- Has experienced CLL progression <36 months since the completion of the last prior
therapy

Exclusion:

- Recent history of a major non-CLL malignancy

- Evidence of an ongoing infection

- CLL refractory to bendamustine

- Concurrent participation in another therapeutic clinical trial

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-312-0115

NCT ID:

NCT01569295

Start Date:

May 2012

Completion Date:

December 2016

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • CLL
  • CAL 101
  • CAL-101
  • GS 1101
  • GS-1101
  • PI3K
  • Rituxan
  • Rituximab
  • Bendamustine
  • Leukemia
  • idelalisib
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226
Yakima Valley Memorial HospitalYakima, Washington  98902
Texas Oncology, P.A.Dallas, Texas  75246
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Rocky Mountain Cancer CenterDenver, Colorado  80218
Stanford Cancer CenterStanford, California  94305-5824
Seattle Cancer Care AllianceSeattle, Washington  98109
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
University of FloridaGainesville, Florida  32610-0277
UCLA Medical CenterLos Angeles, California  90095-7059
Dana Farber Cancer InstituteBoston, Massachusetts  02115
M.D. Anderson Cancer CenterHouston, Texas  77030
Providence Holy Cross Medical CenterMission Hills, California  91345
Texas OncologyDallas, Texas  
Charleston Hematology OncologyCharleston, South Carolina  29403
Hematology Oncology Associates of Northern New JerseyMorristown, New Jersey  07960
Clearview Cancer InstituteHuntsville, Alabama  35805
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Texas Oncology PADallas, Texas  75231
Weill Cornell Medical CollegeNew York, New York  10021
Northwest Cancer Specialists, PCPortland, Oregon  97225
Cancer Care Northwest, US OncologySpokane, Washington  99202