Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Bridalveil)
Indolent Non-Hodgkin's Lymphomas
About this trial
This is an interventional treatment trial for Indolent Non-Hodgkin's Lymphomas focused on measuring 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
Eligibility Criteria
Key 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)
Key Exclusion Criteria:
- History of lymphoid malignancy other than those allowed per inclusion criteria.
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Clearview Cancer Institute
- Ironwood Cancer and Research Center
- Comprehensive Blood and Cancer Center (Bakersfield)
- Saint Jude Heritage Healthcare (TORI)
- Pacific Shores Medical Group
- Cancer Care Associates
- San Luis Obispo Oncology and Hematology
- Cancer Center of Santa Barbara
- Central Coast Medical Oncology Group
- St Joseph Heritage Healthcare System
- Kaiser Permanente Vallejo Medical Center
- Sylvester Comprehensive Cancer Center/UMHC
- Cancer Specialists of North Florida
- Northwest Georgia Oncology Centers, PC
- Rush University Medical Center
- Joliet Oncology Hematology Associates Ltd.
- Cancer Center of Kansas
- Rutgers Cancer Institute of New Jersey
- North Shore Hematology/Oncology Associates
- Weill Cornell Medical College
- Signal Point Clinical Research Center, LLC
- Hollings Cancer Center
- Bon Secours Saint Francis Hospital
- Texas Oncology, P.A.
- Charles A. Sammons Cancer Center
- Texas Oncology, P.A.
- Brooke Army Medical Center
- Texas Oncology, P.A.
- Texas Oncology, P.A.
- Swedish Medical Center
- Northwest Medical Specialists
- Aurora BayCare Medical Center
- Froedtert Hospital and Medical College of Wisconsin
- Prince of Wales Hospital
- Haematology and Oncology Clinics of Australia Gold Coast
- Royal Adelaide Hospital
- Adelaide Cancer Centre
- Box Hill Hospital
- Monash Medical Centre
- Saint Vincent's Hospital
- Western Hospital
- Royal Perth Hospital
- Tom Baker Cancer Center
- Cross Cancer Institute
- Fraser Clinical Trials, Inc.
- BC Cancer Agency - Vancouver Centre
- Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
- Royal Victoria Regional Health Centre
- Sunnybrook Health Sciences Centre
- Hôpital Charles Lemoyne
- McGill University Health Centre
- Centre Hospitalier Universitaire de Sherbrooke
- Centre Hospitalier Affilie Universitaire de Quebec
- CancerCare Manitoba
- Fakultní Nemocnice Ostrava
- Fakultní nemocnice Brno
- Fakultní nemocnice Hradec Králové
- CHR Metz
- Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
- Institut Bergonié
- Centre Henri-Becquerel
- Hôpital Necker-Enfants Malades
- Centre Jean Bernard
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire Brest
- Centre Hospitalier de Dunkerque
- Centre Hospitalier Départmental La Roche sur Yon
- Centre Léon Bérard
- Institut Paoli Calmettes
- Hôpital Hôtel-Dieu
- Centre Hospitalier Universitaire de Poitiers
- Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
- Institut Gustave Roussy
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
- Gemeinschaftspraxis Dres. Söling Und Siehl
- Vivantes Klinikum am Urban
- Charite - Campus Virchow
- Klinikum der Ludwig-Maximilians-Universität München
- Barzilai Medical Center
- Soroka University Medical Center
- Rambam Health Corp.
- Hadassah Medical Organization, Ein Kerem
- Centro di Riferimento Oncologico di Aviano
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Spedali Civili Di Brescia Azienda Ospedaliera
- IRCCS Azienda Ospedaliera Universitaria San Martino
- Ospedale San Raffaele-IRCCS
- Azienda Ospedaliera Ospedale Niguarda Ca' Granda
- Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
- Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Dong-A University Medical Center
- Seoul National University Hospital
- Samsung Medical Center
- Asan Medical Center
- Uniwersyteckie Centrum Kliniczne
- Malopolskie Centrum Medyczne S.C.
- Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
- Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
- Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
- Centralny Szpital Kliniczny MSW w Warszawie
- Instytut Hematologii i Transfuzjologii
- Centrum Onkologii i Hipertermii
- Sverdlovsk Regional Clinical Hospital #1
- Central City Hospital # 7
- N. N. Blokhin Russian Cancer Research Center
- Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
- Ryazan Regional Clinical Hospital
- FGU Russian Scientific Research Institute of Hematology and Transfusiology
- FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
- Saint Petersburg I.P. Pavlov State Medical University
- Saratov State Medical University
- State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
- Hospital Universitario Puerta de Hierro
- Hospital Universitari Germans Trias i Pujol
- Hospital Universitario La Princesa
- Hospital General Universitario Gregorio Marañon
- Hospital Clínico Universitario de Salamanca
- Hospital Universitario de Canarias
- Hospital Universitario Virgen del Rocio
- Hospital Universitari i Politecnic La Fé de Valencia
- Karolinska Universitetssjukhuset
- Länssjukhuset Ryhov
- Changhua Christian Hospital
- China Medical University Hospital
- National Cheng-Kung University Hospital
- National Taiwan University Hospital
- Kent and Canterbury Hospital
- University Hospital Coventry
- Royal Bournemouth General Hospital
- Leeds Teaching Hospitals NHS Trust
- Barts and The London NHS Trust
- University College London Hospitals National Health Society Foundation Trust
- Guys and Saint Thomas NHS Foundation Trust
- Imperial College Healthcare NHS Trust
- Maidstone Hospital
- Christie Hospital NHS Foundation Trust
- Oxford University Hospitals NHS Trust
- Southampton General Hospital
- Mount Vernon Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Rituximab + Bendamustine + Idelalisib
Rituximab + Bendamustine + Placebo
Participants will receive rituximab + bendamustine + idelalisib.
Participants will receive rituximab + bendamustine + placebo.