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:
Gilead Sciences
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
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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:
|
|
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
- Follicular lymphoma (FL) Grade 1, 2, or 3a
- Small lymphocytic lymphoma (SLL)
- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- 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