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
18 Years
N/A
Both
Indolent Non-Hodgkin's Lymphomas
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 |
