A Study Evaluating the Efficacy and Safety of Idelalisib(GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

This study is currently recruiting participants.
Verified May 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01732926
First received: November 14, 2012
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control.


Condition Intervention Phase
Indolent Non-Hodgkin's Lymphomas
Drug: Rituximab IV 375mg/m2 every 28 days for 4 cycles
Drug: bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles
Drug: idelalisib orally 150mg BID
Drug: Placebo orally 150mg BID
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Assessed every 12 weeks until progression. ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Tumor control [ Time Frame: Assessed every 12 weeks until progression ] [ Designated as safety issue: No ]
    To evaluate the effect of the addition of idelalisib (GS-1101) to bendamustine/rituximab on the onset, magnitude, and duration of tumor control.

  • Overall well-being [ Time Frame: Assessed until death regardless of cause. ] [ Designated as safety issue: Yes ]
    To assess the effect of the addition of idelalisib (GS-1101) to bendamustine/rituximab on measures of subject well-being, including overall survival, health related quality of life, and performance status

  • Safety profile [ Time Frame: Assessed every 12 weeks until progression and 30 days post last dose. ] [ Designated as safety issue: Yes ]
    To describe the overall safety profile observed with the addition of idelalisib (GS-1101) to bendamustine/rituximab characterized by the type, frequency, severity, timing of onset, duration, and relationship to study therapy of any adverse events or abnormalities of laboratory tests; serious adverse events; or adverse events leading to discontinuation of study treatment


Estimated Enrollment: 450
Study Start Date: December 2012
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen A
Rituximab IV 375mg/m2 every 28 days for 4 cycles; bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles; idelalisib (GS-1101) orally 150mg BID
Drug: Rituximab IV 375mg/m2 every 28 days for 4 cycles Drug: bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles Drug: idelalisib orally 150mg BID
Other Names:
  • CAL-101
  • GS-1101
Experimental: Regimen B
Rituximab IV 375mg/m2 every 28 days for 4 cycles; bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles; Placebo orally BID
Drug: Rituximab IV 375mg/m2 every 28 days for 4 cycles Drug: bendamustine 90mg/m2 for 2 consecutive days every 28 days for 4 cycles Drug: Placebo orally 150mg BID

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732926

Contacts
Contact: Shelley E Evans, BS 206.256.4974 shelley.evans@gilead.com

Locations
United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
Contact: Kathy Cutter     256-705-4248     kathyc@ccihsv.com    
Contact: Leslie Smoot     1 (256) 705-4283     leslies@ccihsv.com    
Principal Investigator: Marshall Schreeder, M.D.            
United States, California
Providence Saint Joseph Medical Center-Disney Family Cancer Center Recruiting
Burbank, California, United States, 91505
Contact: Donna Fernando     818-748-4770     donna.fernando@providence.org    
Principal Investigator: Peter Rosen, M.D.            
Pacific Shores Medical Group Recruiting
Long Beach, California, United States, 90813
Contact: Irene De Jesus     562-590-0345     irened@pacshoresoncology.com    
Contact: Victoria Langsang     1 (562) 590-0345     victorial@pacshoresoncology.com    
Principal Investigator: André Liem, M.D.            
United States, Connecticut
Middlesex Hospital Cancer Center Recruiting
Middletown, Connecticut, United States, 06457
Contact: Bertha Robbins     860-358-2000     bertha_robbins@midhosp.org    
Principal Investigator: Robert Levy, M.D.            
United States, Florida
Collaborative Research Group, LLC Recruiting
Boynton Beach, Florida, United States, 33435
Contact: Maggie Szymczak     561-209-2062 ext 104     mszymczak@crgresearch.org    
Principal Investigator: Armando Armas, M.D.            
Cancer Care of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Contact: Edrelyn Rosario     904-739-4847     edrelyn.rosario@cancerspecialistsnf.com    
Contact: Barbara Harris     1 (904) 739-4845     barbara.harris@cancerspecialistsnf.com    
Principal Investigator: Mehdi Moezi, M.D.            
United States, Georgia
Northwest Georgia Oncology Centers, PC Recruiting
Marietta, Georgia, United States, 30060
Contact: Mary Gilley     770-281-5131     mgilley@ngoc.com    
Contact: Vanessa Teague     1 (770) 281-5101     vteague@ngoc.com    
Principal Investigator: Robert Hermann, M.D.            
United States, Illinois
Medical and Surgical Specialists, LLC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Linda Ferry     309-343-3024     lferry@grics.net    
Contact: Dori Olin     1 (309) 343-3024     dolin@grics.net    
Principal Investigator: John McClean, M.D.            
Joliet Oncology Hematology Associates Ltd. Recruiting
Joliet, Illinois, United States, 60435
Contact: Angela Malone     815-730-3033 ext 1257     amalone@jolietoncology.com    
Contact: Karen Sceniak     1 (815) 730-3098     ksceniak@jolietoncology.com    
Principal Investigator: Kulumani Sivarajan, M.D.            
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Contact: Lisbeth Lynn     847-827-9060     lisbeth.lynn@usoncology.com    
Contact: Pian Moy     1 (847) 827-9060     pian.moy@usoncology.com    
Principal Investigator: Leonard Klein, M.D.            
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214
Contact: Renee Schott     316-613-4314     renee.schott@cancercenterofkansas.com    
Principal Investigator: Shaker Dakhil, M.D.            
United States, Maryland
Center for Cancer and Blood Disorders, PC Recruiting
Bethesda, Maryland, United States, 20817
Contact: Natalie Bongiorno, BSN, MSHS     240-482-0526     nbongiorno@ccbdmd.com    
Principal Investigator: Ralph Boccia, M.D.            
Maryland Oncology Hematology, P.A. Recruiting
Columbia, Maryland, United States, 21044
Contact: Denise Carter-Brookins, B.S.     410-964-2212 ext 1137     denise.carter-brookins@usoncology.com    
Principal Investigator: Edward Lee, M.D.            
United States, Michigan
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Zelda Smith     269-373-7447     zsmith@wmcc.org    
Contact: Wendi Mitchell     1 (269) 373-7443     wmitchell@wmcc.org    
Principal Investigator: Raymond Lord, III, M.D. FACP            
United States, Mississippi
Jackson Oncology Associates, PLLC Recruiting
Jackson, Mississippi, United States, 39202
Contact: Teresa Davis     601-974-5547     teresadavis@mbhs.org    
Contact: Heather Brashier     1 (601) 974-5543     hbrashier@mbhs.org    
Principal Investigator: Grace Shumaker, M.D.            
United States, North Carolina
Cornerstone Hematology/Oncology Recruiting
High Point, North Carolina, United States, 27262
Contact: Julie McClain     336-802-2502 ext 3671     julie.mcclain@cornerstonehealthcare.com    
Principal Investigator: Vallathucherry Harish, M.D.            
United States, Ohio
Signal Point Clinical Research Center, LLC Recruiting
Middletown, Ohio, United States, 45042
Contact: Kendra Rutschilling     513-423-0504     kendrar@swohio.twcbc.com    
Contact: Catherine Schweitzer     1 (513) 423-0504     cschweitzer@swohio.twcbc.com    
Principal Investigator: Nandagopal Vrindavanam, M.D.            
United States, South Dakota
Prairie Lakes Healthcare System Recruiting
Watertown, South Dakota, United States, 57252
Contact: Lisa Campbell     605-882-6800     lisa.campbell@prairielakes.com    
Principal Investigator: Bipinkumar Amin, M.D.            
United States, Washington
Northwest Medical Specialists Recruiting
Tacoma, Washington, United States, 98405
Contact: Debi Kadoun     253-396-5334     dkadoun@nwmsonline.com    
Principal Investigator: Moacyr de Oliveira, M.D.            
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Wayen Godfrey, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732926     History of Changes
Other Study ID Numbers: GS-US-313-0125
Study First Received: November 14, 2012
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013