Non Hodgkin Lymphoma Clinical Trial
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Summary
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.
An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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:
Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
No prior therapy for CLL other than corticosteroids for disease complications
CLL that warrants treatment
Presence of measurable lymphadenopathy
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Key Exclusion Criteria:
Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
Known presence of myelodysplastic syndrome
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
Ongoing liver injury
History of non-infectious pneumonitis
Ongoing inflammatory bowel disease
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
Ongoing immunosuppressive therapy other than corticosteroids
Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 89 Locations for this study
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Santa Maria California, 93454, United States
Washington District of Columbia, 20007, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32256, United States
Sarasota Florida, 34236, United States
Indianapolis Indiana, 46237, United States
Sioux City Iowa, 51101, United States
Bethesda Maryland, 20817, United States
Las Vegas Nevada, 89074, United States
Morristown New Jersey, 07962, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45242, United States
Middletown Ohio, 45042, United States
Greenville South Carolina, 29601, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78705, United States
Dallas Texas, 75246, United States
Salt Lake City Utah, 84103, United States
Seattle Washington, 98109, United States
Darlinghurst New South Wales, 2010, Australia
North Gosford New South Wales, 2250, Australia
Waratah New South Wales, 2298, Australia
Adelaide South Australia, 5000, Australia
Bedford Park South Australia, 5042, Australia
Kurralta Park South Australia, 5037, Australia
Woodville South South Australia, 5011, Australia
Frankston Victoria, 3199, Australia
Geelong Victoria, 3220, Australia
Antwerpen , 2060, Belgium
Brugge , 8000, Belgium
Leuven , 3000, Belgium
Winnipeg Manitoba, R3E 0, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H4J 1, Canada
Quebec City Quebec, G1J 1, Canada
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Ostrava-Poruba Moravian-Silesian, 70852, Czechia
Brno , 62500, Czechia
Hradec Kralove , 500 0, Czechia
Plzen , 304 6, Czechia
Prague 10 , 10034, Czechia
Lille , 59037, France
Paris , 75010, France
Tours , 37044, France
Tatabánya Komárom - Esztergom, 2800, Hungary
Kaposvar Somogy, 7400, Hungary
Budapest , 1083, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Gyula , 5700, Hungary
Pecs , 7624, Hungary
Szeged , 6725, Hungary
Bari Puglia, 70024, Italy
Cagliari , 09121, Italy
Milan , 20132, Italy
Modena , 41124, Italy
Novara , 28100, Italy
Gdańsk Pomorskie, 80-95, Poland
Krakow , 30-51, Poland
Lodz , 93-51, Poland
Warsaw , 02-50, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-36, Poland
Wroclaw , 53-43, Poland
Brasov , 50032, Romania
Bucharest , 20125, Romania
Barcelona Cataluña, 08035, Spain
Barcelona Cataluña, 08036, Spain
Barcelona , 8041, Spain
Barcelona , 8908, Spain
Madrid , 28006, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28041, Spain
Madrid , 28222, Spain
London England, WC1E , United Kingdom
Canterbury Kent, CT1 3, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Cardiff , CF14 , United Kingdom
Liverpool , L7 8X, United Kingdom
London , W12 0, United Kingdom
Oxford , OX37L, United Kingdom
Southampton , SO16 , United Kingdom
Wolverhampton , WV10 , United Kingdom
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