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A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: Idelalisib (Drug); Rituximab (Drug); Bendamustine (Drug); Placebo to match idelalisib (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Henry Adewoye, MD, Study Director, Affiliation: Gilead Sciences

Summary

This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1: 1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.

Clinical Details

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 Chronic Lymphocytic Leukemia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Progression-Free Survival

Secondary outcome:

Overall Response Rate

Lymph Node Response Rate

Overall Survival

Complete Response Rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion:

- Previously treated recurrent CLL

- Measurable lymphadenopathy

- Requires therapy for CLL

- Has experienced CLL progression <36 months since the completion of the last prior

therapy Exclusion:

- Recent history of a major non-CLL malignancy

- Evidence of an ongoing infection

- CLL refractory to bendamustine

- Concurrent participation in another therapeutic clinical trial

Locations and Contacts

Princess Alexandra Hospital, Woolloongabba 4102, Australia

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg, Antwerpen 2060, Belgium

UZ Gent, Gent 9000, Belgium

UZ Leuven, Leuven 3000, Belgium

Clinical Hospital "Dubrava", Zagreb 10000, Croatia

Klinichki Bolnicki Centar-Zagreb, Zagreb 10000, Croatia

University Hospital Merkur, Zagreb 10000, Croatia

Fakultni nemocnice Brno, Brno 625 00, Czech Republic

Fakultni nemocnice Hradec Kralove, Hradec Kralove 500 05, Czech Republic

Fakultni nemocnice Ostrava, Ostrava 708 52, Czech Republic

Hôpital Henri Mondor, Creteil 94010, France

Centre Jean Bernard - Clinique Victor Hugo, Le Mans cedex 72015, France

CHRU Lille-Hôpital Claude Huriez, Lille 59045, France

Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes, Lyon 69373, France

Centre Hospitalier de Mulhouse, Mulhouse 68100, France

CHU Hôtel-Dieu-Service Hématologie, Nantes 44 093, France

Hopital Cochin, Paris 75104, France

Centre Hospitalier Lyon Sud, Pierre Bénite Pierre Bénite, France

Hopital Purpan, Toulouse 31059, France

Hôpitaux de Brabois, Vandoeuvre-lés-Nancy 54511, France

G. Genimatas Hospital, Athens 11527, Greece

University General Hospital of Patras, Patras 26500, Greece

Országos Onkológiai Intézet, Budapest 1122, Hungary

Semmelweis Egyetem, Budapest 1083, Hungary

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Debrecen 4032, Hungary

Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár 7400, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged 6720, Hungary

Mater Misericordiae Hospital, Dublin, Ireland

Spedali Civili di Brescia, Brescia 25123, Italy

Ospedale Oncologico Regionale A. Businco, Cagliari 9121, Italy

Azienda Ospedaliera Niguarda Ca Granda, Milano 20162, Italy

O Spedale San Rafaelle S.r.l., Milano 20132, Italy

Policlinico Universitario "A. Gemelli", Roma 00168, Italy

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino 10126, Italy

Wellington Hospital, Wellington South, New Zealand

Szpital Specjalistyczny w Brzozowie, Brzozow 36-200, Poland

Malopolskie Centrum Medyczne, Krakow 30-510, Poland

Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz 93-510, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin 20-081, Poland

Wojewodzki Szpital w Opolu, Opole 43-372, Poland

Centralny Szpital Kliniczny MSW w Warszawie, Warszawa 02-507, Poland

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Warszawa 02-781, Poland

Hospital Santa Maria, Lisboa 1649-035, Portugal

"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE), Porto 4200-072, Portugal

Policlinica de Diagnostic Rapid SA, Brasov 500152, Romania

"Colentina" Clinical Hospital, Bucharest, Romania

"Fundeni" Clinical Institute, Bucharest 22328, Romania

Regional Oncology Institute Iasi, Iasi 700483, Romania

Russian Oncology Research Center (N.N. Blokhin), Moscow 115478, Russian Federation

Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko, Nizhniy Novgorod 603126, Russian Federation

Novosibirsk State Regional Clinical Hospital, Novosibirsk, Russian Federation

Ryazan Regional Clinical Hospital, Ryazan 390039, Russian Federation

Saratov State Medical University, Saratov 410028, Russian Federation

Research Institute of Hematology and Blood Transfusion, St. Petersburg 193024, Russian Federation

Volgograd Regional Oncology Center #1, Volgograd 400138, Russian Federation

Hospital Universitario de La Princesa, Madrid 28033, Spain

Ankara University Medical Faculty, Ankara 6590, Turkey

Gazi University Medical Faculty Gazi Hospital, Ankara 06500, Turkey

Istanbul University Istanbul Medical Faculty, Istanbul 34093, Turkey

Ondokuz Mayis University Faculty of Medicine, Samsun 55239, Turkey

Birmingham Heartlands Hospital, Birmingham B9 5SS, United Kingdom

Kent and Canterbury Hospital, Canterbury CT1 3NG, United Kingdom

University Hospital of Wales, Cardiff CF14 4XW, United Kingdom

Dorset County Hospital, Dorchester DT1 2JY, United Kingdom

St James's University Hospital, Leeds LS9 7TF, United Kingdom

Royal Liverpool University Hospital, Liverpool L7 8XP, United Kingdom

Hammersmith Hospital, London W12 0NN, United Kingdom

King's College Hospital, London SE5 9RS, United Kingdom

St Bartholomews Hospital, London EC1A 7BE, United Kingdom

University College London, London NW1 2PG, United Kingdom

Christie Hospital, Manchester M20 4BX, United Kingdom

Nottingham University Hospitals NHS Trust, Nottingham NG51PB, United Kingdom

Churchill Hospital, Oxford OX3 7LE, United Kingdom

Royal Cornwall Hospital, Truro TR1 3LJ, United Kingdom

New Cross Hospital, Wolverhampton WV10 0QP, United Kingdom

Clearview Cancer Institute, Huntsville, Alabama 35805, United States

Stanford Cancer Center, Palo Alto, California 94304, United States

UCLA Medical Center, Santa Monica, California 90404, United States

Hospital Universitario Germans Trias i Pujol, Badalona, Cataluña 08916, Spain

Hospital Clinic de Barcelona, Barcelona, Cataluña 8036, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña 8041, Spain

Rocky Mountain Cancer Center, Denver, Colorado 80218, United States

University of Florida, Gainsville, Florida 32610, United States

Winship Cancer Institute at Emory University, Atlanta, Georgia 30322, United States

Hospital 12 de Octubre, Madrid, Madrid, Communidad de 28041, Spain

Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Communidad de 28222, Spain

Cancer Care Manitoba, Winnipeg, Manitoba R3A 1R9, Canada

Dana Farber Cancer Institute, Boston, Massachusetts 02215, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

Hackensack University Medical Center, Hackensack, New Jersey 07601, United States

Hematology Oncology Associates of Northern New Jersey, Morristown, New Jersey 07962, United States

St Vincent's Hospital - Sydney, Darlinghurst, New South Wales 2010, Australia

Gosford Hospital, Gosford, New South Wales 2250, Australia

Long Island Jewish Medical Center, New Hyde Park, New York 11042, United States

Columbia University Medical Center, New York, New York 10032, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

Willamette Valley Cancer Center, Eugene, Oregon 97401, United States

Northwest Cancer Specialists, PC, Portland, Oregon 97225, United States

Royal Adelaide Hospital, Adelaide, South Australia 5000, Australia

Charleston Hematology Oncology, Charleston, South Carolina 29414, United States

Texas Oncology, Austin, Texas 78731, United States

Texas Oncology PA, Dallas, Texas 78246, United States

Texas Oncology, P.A., Fort Worth, Texas 76104, United States

M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Monash Medical Centre - Clayton Campus, Clayton, Victoria 3168, Australia

Seattle Cancer Care Alliance, Seattle, Washington 98109, United States

Cancer Care Northwest, US Oncology, Spokane, Washington 99202, United States

Yakima Valley Memorial Hospital, Yakima, Washington 98902, United States

Sir Charles Gairdner Hospital, Nedlands, Western Australia 6009, Australia

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: June 2012
Last updated: May 1, 2015

Page last updated: August 23, 2015

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