Non Hodgkin Lymphoma Clinical Trial
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
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.
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There are 103 Locations for this study
Huntsville Alabama, 35805, United States
Chandler Arizona, 85224, United States
Duarte California, 91010, United States
Fullerton California, 92835, United States
Long Beach California, 90813, United States
Los Angeles California, 90095, United States
Redondo Beach California, 90277, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Middletown Connecticut, 06457, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33916, United States
Tampa Florida, 33612, United States
Wichita Kansas, 67214, United States
Detroit Michigan, 48201, United States
Las Vegas Nevada, 89169, United States
Bronx New York, 10467, United States
New York New York, 10029, United States
New York New York, 10065, United States
Cleveland Ohio, 44109, United States
Middletown Ohio, 45042, United States
Philadelphia Pennsylvania, 19104, United States
Watertown South Dakota, 57252, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Bedford Texas, 76022, United States
Fort Sam Houston Texas, 78234, United States
Fort Worth Texas, 76104, United States
Winchester Virginia, 22601, United States
Seattle Washington, 98101, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53226, United States
Milton Queensland, 4064, Australia
Box Hill Victoria, 3128, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Footscray Victoria, 3011, Australia
Perth Western Australia, 6000, Australia
Kurralta Park , SA 50, Australia
Murdoch , 6150, Australia
Hradec Králové , 500 0, Czechia
Pessac Aquitaine, 33604, France
Paris Ile-de-france, 75015, France
Lille cedex NORD Pas-de-calais, 59037, France
Brest , 29609, France
Dunkerque , 59385, France
Le Chesnay , 78157, France
Lyon Cedex 08 , 69373, France
Nantes cedex 1 , 44093, France
Pierre Bénite Cedex , 69495, France
Poitiers Cedex , 86000, France
Villingen-Schwenningen Baden-wuerttemberg, 78052, Germany
Kassel Hessen, 34119, Germany
Debrecen Hajdu-bihar, 4032, Hungary
Kaposvár Somogy, 7400, Hungary
Szombathely VAS, 9700, Hungary
Budapest , 1083, Hungary
Budapest , 1122, Hungary
Jerusalem , 91120, Israel
Petach Tikva , 49100, Israel
Bologna , 40138, Italy
Novara , 28100, Italy
Pesaro , 61100, Italy
Pordenone , 33081, Italy
Torino , 10126, Italy
Nagoya City Aichi, 467-8, Japan
Nagoya-shi Aichi, 46000, Japan
Nagoya Aichi, 464-8, Japan
Minami Ku Fukuoka, 811-1, Japan
Kobe-city Hyogo, 650-0, Japan
Isehara-shi Kanagawa, 259-1, Japan
Chuo-ku Kumamoto, 860-0, Japan
Sendai Miyagi, 98085, Japan
Okayama-city Okayama, 700-8, Japan
Osaka-shi Osaka, 545-8, Japan
Chuo-ku Tokyo, 10400, Japan
Koto-ku Tokyo, 135-8, Japan
Minato-ku Tokyo, 10584, Japan
Seoul , 110-7, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Seoul , 138-8, Korea, Republic of
Kraków , 30-51, Poland
Olsztyn , 10-22, Poland
Warszawa , 02-78, Poland
Porto , 4099-, Portugal
Bucuresti , 02232, Romania
Ekaterinburg , 62010, Russian Federation
Nizhniy Novgorod , 60312, Russian Federation
Ryazan , 39003, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint-Petersburg , 19702, Russian Federation
Saratov , 410 0, Russian Federation
Singapore , 16960, Singapore
Singapore , 16961, Singapore
Singapore , 25850, Singapore
Majadahonda Madrid, 28222, Spain
Badalona , 08916, Spain
Malmö , 205 0, Sweden
Kaohsiung , 83301, Taiwan
Taipei , 11490, Taiwan
London England, EC1A , United Kingdom
Middlesex , HA6 2, United Kingdom
Sunderland , SR4 7, United Kingdom
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