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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 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 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) in combination with 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) with absolute lymphocyte count <5 x 109/L
at the time of diagnosis

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.

- Received previous 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 rituximab on progression-free survival in subjects with previously treated indolent non-Hodgkin lymphoma (iNHL)

Outcome Time Frame:

Every 12 weeks

Safety Issue:

No

Principal Investigator

Wayne Godfrey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-313-0124

NCT ID:

NCT01732913

Start Date:

December 2012

Completion Date:

June 2022

Related Keywords:

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

Name

Location

Middlesex Hospital Cancer CenterMiddletown, Connecticut  06457
Pacific Shores Medical GroupLong Beach, California  90813
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Northwest Medical Specialties, PLLCTacoma, Washington  98405
Clearview Cancer InstituteHuntsville, Alabama  35805
Medical and Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Center of KansasWichita, Kansas  67214
Essex Oncology of North Jersey, PABelleville, New Jersey  07109
Center for Cancer and Blood Disorders, PCBethesda, Maryland  20817
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Illinois Cancer SpecialistsNiles, Illinois  60714
Collaborative Research Group, LLCBoynton Beach, Florida  33435
Providence Saint Joseph Medical Center-Disney Family Cancer CenterBurbank, California  
Cornerstone Hematology/OncologyHigh Point, North Carolina  27262
Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania  19104
Prairie Lakes Healthcare SystemWatertown, South Dakota  57252