Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Yosemite)
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, Small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenstrom macroglobulinemia, LPL, WM, Marginal zone lymphoma, MZL, SLL, FL, GS-1101, 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) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
- 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.
- Received previous treatment with rituximab that was not effective.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Clearview Cancer Institute
- Ironwood Cancer and Research Center
- City of Hope Cancer Center
- Saint Jude Heritage Healthcare
- Pacific Shores Medical Group
- UCLA Medical Center
- Cancer Care Associates
- Cancer Center of Santa Barbara
- Central Coast Medical Oncology Group
- Middlesex Hospital Cancer Center
- Georgetown University Medical Center
- Florida Cancer Specialists and Research Institute
- Moffitt Cancer Center
- Cancer Center of Kansas
- Wayne State University
- Comprehensive Cancer Centers of Nevada
- Montefiore Medical Center
- Icahn School of Medicine at Mount Sinai
- Weill Cornell Medical College
- MetroHealth Medical Center
- Signal Point Clinical Research Center, LLC
- Perelman Center for Advanced Medicine
- Prairie Lakes Healthcare System
- Tennessee Oncology, PLLC
- Sarah Cannon Cancer Center
- Texas Oncology, P.A.
- Brooke Army Medical Center
- Center for Cancer and Blood Disorders, PC
- Shenandoah Oncology Associates, PC
- Virginia Mason Medical Center
- Northwest Medical Specialties, PLLC
- Froedtert Hospital and Medical College of Wisconsin
- Haematology and Oncology Clinics of Australia at Chermside
- Box Hill Hospital
- Monash Medical Centre
- Saint Vincent's Hospital
- Western Hospital
- Royal Perth Hospital
- Adelaide Cancer Centre
- Fiona Stanley Hospital
- Fakultní nemocnice Hradec Králové
- University Hospital of Bordeaux
- Hôpital Necker-Enfants Malades
- Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
- Centre Hospitalier Universitaire Brest
- Centre Hospitalier de Dunkerque
- Centre Hospitalier de Versailles
- Centre Léon Bérard
- Hôpital Hôtel-Dieu
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
- Gemeinschaftspraxis Dres. Söling Und Siehl
- Debreceni Egyetem Orvos-és Egészségtudományi Centrum
- Somogy Megyei Kaposi Mór Oktató Kórház
- Markusovszky Egyetemi Oktatókórház
- Semmelweis Egyetem
- Országos Onkológiai Intézet
- Hadassah Medical Organization, Ein Kerem
- Rabin Medical Center
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Centro di Riferimento Oncologico di Aviano
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Nagoya City University Hospital
- National Hospital Organization Nagoya Medical Center
- Aichi Cancer Center Hospital
- National Hospital Organization Kyushu Cancer Center
- Kobe City Medical Center General Hospital
- Tokai University Hospital
- National Hospital Organization Kumamoto Medical Center
- Tohoku University Hospital
- Okayama University Hospital
- Osaka City University Hospital
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- Toranomon Hospital
- Seoul National University Hospital
- Samsung Medical Center
- Asan Medical Center
- Malopolskie Centrum Medyczne S.C.
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
- Centrum Onkologii i Hipertermii
- Hospital Geral de Santo António do Centro Hospitalar do Porto
- Institutul Clinic Fundeni
- Sverdlovsk Regional Clinical Hospital #1
- Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
- Ryazan Regional Clinical Hospital
- 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
- Singapore General Hospital
- National Cancer Centre Singapore
- Gleneagles Medical Centre
- Hospital Universitario Puerta de Hierro
- Hospital Universitari Germans Trias i Pujol
- Skånes Universitetssjukhus, Malmö
- Chang Gung Memorial Hospital (CGMH)
- Tri-Service General Hospital
- Barts and The London NHS Trust
- Mount Vernon Hospital
- Sunderland Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Rituximab + idelalisib
Rituximab + Placebo
Participants will receive rituximab + idelalisib.
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.