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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 Indolent Non-Hodgkin Lymphomas


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Indolent Non-Hodgkin's Lymphomas

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 Indolent Non-Hodgkin Lymphomas


This is a Phase 3, multicenter, 2-arm, randomized, double-blind, placebo-controlled clinical
trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta
(PI3K-delta) inhibitor idelalisib (GS-1101)GS-1101 in combination with bendamustine and
Rituximab for previously treated indolent non-Hodgkin lymphomas.

Eligible subjects will be randomized with a 2:1 allocation to Regimen A vs. Regimen B.


Inclusion Criteria:



- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following

1. Follicular lymphoma (FL) Grade 1, 2, or 3a

2. Small lymphocytic lymphoma (SLL)

3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Exclusion Criteria:

- Known histological transformation to an aggressive lymphoma

- Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B , alcoholic
liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic
obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.

- Prior treatment with bendamustine that was not effective.

- Prior treatment with rituximab that was not effective.

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 Description:

To evaluate the effect of the addition of idelalisib (GS-1101) to bendamustine/rituximab on progression-free survival in subjects with previously treated indolent non-Hodgkin lymphoma (iNHL)

Outcome Time Frame:

Assessed every 12 weeks until progression.

Safety Issue:

No

Principal Investigator

Wayen Godfrey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-313-0125

NCT ID:

NCT01732926

Start Date:

December 2012

Completion Date:

September 2022

Related Keywords:

  • Indolent Non-Hodgkin's Lymphomas
  • iNHL
  • indolent NHL
  • follicular lymphoma
  • CAL-101
  • Rituximab
  • Bendamustine
  • small lymphocytic lymphoma
  • lymphoplasmacytoid lymphoma
  • Waldenstrom macroglobulinemia
  • LPL
  • WM
  • Marginal zone lymphoma
  • MZL
  • SLL
  • FL
  • GS-1101
  • PI3K inhibitor
  • idelalisib
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Middlesex Hospital Cancer Center Middletown, Connecticut  06457
Pacific Shores Medical Group Long Beach, California  90813
Jackson Oncology Associates, PLLC Jackson, Mississippi  39202
Clearview Cancer Institute Huntsville, Alabama  35805
Medical and Surgical Specialists, LLC Galesburg, Illinois  61401
Cancer Center of Kansas Wichita, Kansas  67214
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Cancer Care of North Florida Lake City, Florida  32055
Northwest Medical Specialists Tacoma, Washington  98405
Northwest Georgia Oncology Centers, PC Marietta, Georgia  30060
Center for Cancer and Blood Disorders, PC Bethesda, Maryland  20817
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Illinois Cancer Specialists Niles, Illinois  60714
Collaborative Research Group, LLC Boynton Beach, Florida  33435
Providence Saint Joseph Medical Center-Disney Family Cancer Center Burbank, California  
Cornerstone Hematology/Oncology High Point, North Carolina  27262
Prairie Lakes Healthcare System Watertown, South Dakota  57252
Joliet Oncology Hematology Associates Ltd. Joliet, Illinois  60435