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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01569295
First received: March 27, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Idelalisib
Drug: Rituximab
Drug: Bendamustine
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response.

  • Lymph Node Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Lymph node response rate is defined as the proportion of participants who achieve a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.

  • Overall Survival [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Overall survival (OS) is defined as the interval from randomization to death from any cause.

  • Complete Response Rate [ Time Frame: Baseline to Month 30 ] [ Designated as safety issue: No ]
    Complete response (CR) rate is defined as the proportion of participants who achieve a CR.


Estimated Enrollment: 390
Study Start Date: June 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Idelalisib + bendamustine/rituximab Drug: Idelalisib
Idelalisib 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL 101
  • CAL-101
Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 administered intravenously thereafter
Other Name: Rituxan, MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously
Other Name: Ribomustin, Treanda, SDX-105
Placebo Comparator: Placebo + bendamustine/rituximab Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 administered intravenously thereafter
Other Name: Rituxan, MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously
Other Name: Ribomustin, Treanda, SDX-105
Drug: Placebo
Placebo to match idelalisib administered orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569295

Contacts
Contact: Maria Aiello, MA 206-256-4927 maria.aiello@gilead.com

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute Recruiting
Huntsville, Alabama, United States, 35805
Contact: Kathy Cutter    256-705-4248      
United States, California
Providence Holy Cross Medical Center Recruiting
Mission Hills, California, United States, 91345
Contact: Cathy Madrid    818-365-3099    cathy.madrid@providence.org   
Stanford Cancer Center Recruiting
Palo Alto, California, United States, 94304
Contact: Zayna Shaheen    650-723-5957    zshaheen@stanford.edu   
UCLA Medical Center Recruiting
Santa Monica, California, United States, 90404
Contact: Ashlee Gonzales    310-829-5471      
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Denver, Colorado, United States, 80218
Contact: Katherine Schleich    303-388-4876    katherine.schleich@usoncology.com   
United States, Florida
University of Florida Recruiting
Gainsville, Florida, United States, 32610
Contact: Cathy Spears    352-265-0680 ext 87658    cdspears@ufl.edu   
United States, Georgia
Winship Cancer Institute at Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Leonard T. Heffner, Jr., MD    404-778-5871    lheffne@emory.edu   
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Elizabeth Coughlin       ElizabethO_Coughlin@DFCI.HARVARD.EDU   
United States, Minnesota
Minnesota Oncology Hematology, PA Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Lynn Anderson    612-884-6300    lynn.anderson@usoncology.com   
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Susan Blumel,    402-559-9183    sblumel@unmc.edu   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Marisa Valentinetti    201-336-8073    mvalentinetti@hackensackumc.org   
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Marisa Valentinetti    201-336-8073    mvalentinetti@hackensackumc.org   
Contact: Judith Smith    (201) 996-5078    judithsmith@hackensackumc.org   
Hematology Oncology Associates of Northern New Jersey Recruiting
Morristown, New Jersey, United States, 07962
Contact: Michelle Mackenzie       mmackenzie@hoannj.com   
United States, New York
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11042
Contact: Kaur Manmeen    516-470-4050    Mkaur5@nshs.edu   
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Talal Khawaja    646-497-9133      
Contact: Lupe Zuniga-Estrada    (646) 497-9152      
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: James McConnell    212-746-1493    jam2064@med.cornell.edu   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Hanna Weissbrot    212-304-5558    hw2432@mail.cumc.columbia.edu   
United States, Oregon
Willamette Valley Cancer Center Recruiting
Eugene, Oregon, United States, 97401
Contact: Wade Carson    541-683-5001    wade.carson@usoncology.com   
Northwest Cancer Specialists, PC Recruiting
Portland, Oregon, United States, 97225
Contact: Tamyra Batsch    503-291-6233    tamyra.batsch@usoncology.com   
United States, South Carolina
Charleston Hematology Oncology Recruiting
Charleston, South Carolina, United States, 29414
Contact: Deborah McNeal    843-577-6957    d.mcneal@choasc.com   
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29605
Contact: William J Edenfield, MD    864-679-3926    jedenfield@ghs.org   
United States, Texas
Texas Oncology Recruiting
Austin, Texas, United States, 78731
Contact: Lauren Hendrix    512-427-9400    lauren.hendrix@usoncology.com   
Texas Oncology PA Recruiting
Dallas, Texas, United States, 78246
Contact: Rita Lopez    214-370-1000    rita.lopez2@usoncology.com   
Texas Oncology, P.A. Recruiting
Fort Worth, Texas, United States, 76104
Contact: Nori Sullivan       Nori.Sullivan@usoncology.com   
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Susan O'Brien, MD       sobrien@mdanderson.org   
Cancer Care Network of South Texas Recruiting
San Antonia, Texas, United States, 78217
Contact: Elizabeth Guthrie       elizabeth.guthrie@usoncology.com   
Cancer Care Centers of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Patricia Manea    210-595-5300    patricia.manea@usoncology.com   
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Dai Nguyen    206-667-7809    dnguyen@fhcrc.org   
Cancer Care Northwest, US Oncology Recruiting
Spokane, Washington, United States, 99202
Contact: Rachel Garman    509-228-1000    rachel.garman@ccnw.net   
Yakima Valley Memorial Hospital Recruiting
Yakima, Washington, United States, 98902
Contact: Beth Parker    509-574-3493    bethparker@yvmh.org   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Hemavathy Sunderraj       hsunderraj@mcw.edu   
Argentina
Instituto de Hematologia y Medicina Clinica "Dr. Ruben Davoli" Recruiting
Rosario, Argentina, 2000
Contact: Olga Mendez    +543414219426    mendezolga@live.com.ar   
Australia, New South Wales
St Vincent's Hospital - Sydney Recruiting
Darlinghurst, New South Wales, Australia, 2010
Contact: Yen Peng Lim    61293555616    ylim3@stvincents.com.au   
Contact: Patricia Plenge    61293555616    pplenge@stvincents.com.au   
Gosford Hospital Recruiting
Gosford, New South Wales, Australia, 2250
Contact: Mark Lacey    +61243203940    Mark.Lacey@health.nsw.gov.au   
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Chris Hoare    61882222920    christine.hoare@health.sa.gov.au   
Australia, Victoria
Monash Medical Centre - Clayton Campus Recruiting
Clayton, Victoria, Australia, 3168
Contact: Carmen DiCorleto    61395944044    carmen.dicorleto@monashhealth.org   
Contact: Annette Opat    61395944044    annette.opat@monashhealth.org   
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Amanda Verhoosel    61863833215    Amanda.Verhoosel@health.wa.gov.au   
Belgium
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg Recruiting
Antwerpen, Belgium, 2060
Contact: Karen Cox    +32 3 217 74 48    studiebureau.hematologie@zna.be   
Contact: Caroline De Man    +32 3 217 74 48    Caroline.deman@zna.be   
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Contact: Pascale De Graef    +32 3 821 32 32    Pascale.DeGraef@uza.be   
UZ Gent Recruiting
Gent, Belgium, 9000
Contact: Charlotte Dekeyzer    +32 9 332 87 70    charlotte.dekeyzer@uzgent.be   
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Saskia Cremers    +32 16 34 68 90    saskia.cremers@uzleuven.be   
Contact: Hannelore Van Eeckhaute    +32 16 34 19 69    hannelore.vaneeckhaute@uzleuven.be   
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: James B. Johnston, MD    (204) 787-2161    james.johnston@cancercare.mb.ca   
Croatia
Clinical Hospital Osijek Recruiting
Osijek, Croatia, 31000
Contact: Jasminka Sincic-Petricevic, MD    38531511746    sincicpetricevic@yahoo.com   
Clinical Hospital Center Rijeka Recruiting
Rijeka, Croatia, 51000
Contact: Aron Grubesic    38551658504      
Klinichki Bolnicki Centar-Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Sandra Basic Kinda    38512388265      
Clinical Hospital "Dubrava" Recruiting
Zagreb, Croatia, 10000
Contact: Marko Lucijanic    38512903132    markolucijanic@gmail.com   
Clinical Hospital Center "Sestre Milosrdnice" Recruiting
Zagreb, Croatia, 10000
Contact: Iva Ivanko    "3853787168      
University Hospital Merkur Recruiting
Zagreb, Croatia, 10000
Contact: Ljiljana Pomper    38512253222      
Czech Republic
Fakultni nemocnice Brno Recruiting
Brno, Czech Republic, 625 00
Contact: Eva Jelinkova    420532233562    eva.jelinkova@fnbrno.cz   
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Martina Havlickova    +420 495 834 593    martina.havlickova@gmail.com   
Fakultni nemocnice Ostrava Recruiting
Ostrava, Czech Republic, 708 52
Contact: Eva Jaksikova    420597372095    eva.jaksikova@fno.cz   
Contact: Andrea Janotova    420597372095    andrea.janotova@fno.cz   
France
Hopital Avicenne Recruiting
Bobigny, France, 93000
Contact: Florence Cymbalista, PhD, MD    33148955641    florence.cymbalista@avc.aphp.fr   
Centre François Baclesse Recruiting
Caen, France, 14000
Contact: Jean-Pierre Vilque, MD    33231455050    jp.vilque@baclesse.fr   
Hôpital Henri Mondor Recruiting
Creteil, France, 94010
Contact: Feriel Bouabbas    +33 1 49 81 41 82    feriel.bouabbas@hmn.aphp.fr   
Centre Jean Bernard - Clinique Victor Hugo Recruiting
Le Mans cedex, France, 72015
Contact: Hélène Dervaux    +33 2 43 29 79 08    hdervaux_sorecoh@yahoo.fr   
CHRU Lille-Hôpital Claude Huriez Recruiting
Lille, France, 59045
Contact: Franck Morschhauser    +33 3 20 44 60 68    fmorschhauser@gmail.com   
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes Recruiting
Lyon, France, 69373
Contact: Grégoire Cadoz    +33 4 26 55 68 39    gregoire.cadoz@lyon.unicancer.fr   
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68100
Contact: Alice Techer    +33 03 89 64 77 69    alice.techer@ch-mulhouse.fr   
CHU Hôtel-Dieu-Service Hématologie Recruiting
Nantes, France, 44 093
Contact: Anna Testu    +33 2 40 08 32 89    anna.testu@chu-nantes.fr   
Contact: Nathalie Trehet    +33 2-40-08-30-13    Nathalie.TREHET@chu-nantes.fr   
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Ouali Medkour    +33 662 345 155      
Centre Hospitalier Lyon Sud Recruiting
Pierre Bénite, France, Pierre Bénite
Contact: Samuel Moulle    +33 4 78 86 12 03    samuel.moulle@chu-lyon.fr   
Centre hospitalier de Périgueux Recruiting
Périgueux, France, 24019
Contact: Philippe Rodon, MD    33553452759    philippe.rodon@ch-perigueux.fr   
Hopital Purpan Recruiting
Toulouse, France, 31059
Contact: Nogaro Jean-Claude    +33 5 61 77 76 66    nogaro.jc@chu-toulouse.fr   
Hôpitaux de Brabois Recruiting
Vandoeuvre-lés-Nancy, France, 54511
Contact: David Schwartz    +33 3 83 15 37 05    d.schwartz@chu-nancy.fr   
Greece
G. Genimatas Hospital Recruiting
Athens, Greece, 11527
Contact: Maria-Nefeli Nikolaidou-Katsaridou    +302107486796    nefeli.katsaridou@gmail.com   
University General Hospital of Patras Recruiting
Patras, Greece, 26500
Contact: Elleni Kalivioti    +302610999247      
Contact: Panagiota Loukopoulou    +302610999247    giotaloukop@gmail.com   
Hungary
Semmelweis Egyetem Recruiting
Budapest, Hungary, 1083
Contact: Anikó Pordán    36206632898    pordan83@yahoo.co.hu   
Országos Onkológiai Intézet Recruiting
Budapest, Hungary, 1122
Contact: Krisztina Kovács    36304296678      
Contact: Judit Tengerdi    36202909561    judit.tengerdi@coordination.hu   
Debreceni Egyetem Orvos- és Egészségtudományi Centrum Recruiting
Debrecen, Hungary, 4032
Contact: Gabriella Mezei    3652255601    gmezei@gmail.com   
Somogy Megyei Kaposi Mór Oktató Kórház Recruiting
Kaposvár, Hungary, 7400
Contact: Katalin Andok    3682501300      
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Recruiting
Szeged, Hungary, 6720
Contact: Tímea Gurbity-Pálfi    36305358021    timea.gurbity@gmail.com   
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Contact: Katrina Falvey    +353 21 4920098      
Contact: Nessa Gallwey    +353 021 4920051      
Mater Misericordiae Hospital Recruiting
Dublin, Ireland
Contact: Lourdes McAlester    +353 018034831    lmcalester@mater.ie   
Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi Recruiting
Bologna, Italy, 40138
Contact: Lisa Argnani    +39 051 636 3227    lisa.argnani@unibo.it   
Contact: Marta Tschon    +39 051 636 3227    marta.tschon2@unibo.it   
Spedali Civili di Brescia Recruiting
Brescia, Italy, 25123
Contact: Marta Petullà    +39 030 3996269    marta-petulla@hotmail.it   
Ospedale Oncologico Regionale A. Businco Recruiting
Cagliari, Italy, 9121
Contact: Emanuele Angelucci, MD    +39 070 6095312    emnang@tin.it   
Azienda Ospedaliera Niguarda Cà Granda Recruiting
Milano, Italy, 20162
Contact: Chiara Colombo    +39 02 64444941    chiara.colombo@ospedaleniguarda.it   
Ospedale San Raffaele S.r.l. Recruiting
Milano, Italy, 20132
Contact: Lydia Scarfò    +39 347 6866923    scarfo.lydia@hsr.it   
Policlinico Universitario "A. Gemelli" Recruiting
Roma, Italy, 00168
Contact: Luca Laurenti, MD    +390630156016    l.laurenti@rm.unicatt.it   
Azienda Ospedaliera Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Marta Santoro    +39 011 6336107-4565    marta.santoro91@yahoo.it   
New Zealand
Wellington Hospital Recruiting
Wellington South, New Zealand
Contact: Debra Morriss    6449186106    debra.morriss@ccdhb.org.nz   
Poland
Szpital Specjalistyczny w Brzozowie Recruiting
Brzozow, Poland, 36-200
Contact: Jacek Krzanowski    +48 13 430 97 28    jacek.krzanowski@gmail.com   
Malopolskie Centrum Medyczne Recruiting
Krakow, Poland, 30-510
Contact: Wojciech Jurczak, PHD, MD    +48 12 295 41 39    wojciech.jurczak@lymphoma.pl   
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Recruiting
Lodz, Poland, 93-510
Contact: Barbara Cebula-Obrzut    +48 503 90 78 51    barbara_cebula@wp.pl   
Contact: Pawel Robak    +48 42 689 5191      
Samodzielny Publiczny Szpital Kliniczny Nr 1 Recruiting
Lublin, Poland, 20-081
Contact: Malgorzata Wach    mijwach@poczta.onet.pl    mijwach@poczta.onet.pl   
Wojewodzki Szpital w Opolu Recruiting
Opole, Poland, 43-372
Contact: Dariusz Woszczyk, MD, PhD    +48(77) 443 33 54    dariuszwoszczyk@tlen.pl   
Centralny Szpital Kliniczny MSW w Warszawie Recruiting
Warszawa, Poland, 02-507
Contact: Joanna Omyla-Staszewska, MD    +48 22 508 19 80    joannaomyla@gmail.com   
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Recruiting
Warszawa, Poland, 02-781
Contact: Magdalena Barbasiewicz    +48 22 5462426      
Contact: Gabriela Zaleskiewicz-Pietrzak    +48 22 5462426    gabi@coi.waw.pl   
Portugal
Hospital Santa Maria Recruiting
Lisboa, Portugal, 1649-035
Contact: Susana Borrego    +351 217805357      
Centro Hospitalar do Porto, E.P.E. Recruiting
Porto, Portugal, 4099-001
Contact: Rui Fonseca    351918627940    fonseca.rui@hotmail.com   
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE) Recruiting
Porto, Portugal, 4200-072
Contact: Inês Carvalho    351225084008    ines.carvalho@ipoporto.min-saude.pt   
Romania
Emergency County Clinical Hospital Brasov Recruiting
Brasov, Romania, 500326
Contact: Emanuil Gheorghita, MD    +40 268330140    emanuil.gheorghita@yahoo.com   
"Fundeni" Clinical Institute Recruiting
Bucharest, Romania, 22328
Contact: Mariana Vasilica, MD    403180400    v.madalina@yahoo.com   
"Dr. Carol Davila" Emergency Central Military Hospital Recruiting
Bucharest, Romania, 010825
Contact: Mihai-Alexandru Sotcan    +40(72) 2 569 176    sotcanm@yahoo.com   
"Colentina" Clinical Hospital Recruiting
Bucharest, Romania
Contact: Meilin Murat    +40(21) 3 173 245    meilin_26@yahoo.com   
Regional Oncology Institute Iasi Recruiting
Iasi, Romania, 700483
Contact: Catalin Danaila, MD    +40 232 211 218    c_danaila@yahoo.com   
Russian Federation
Russian Oncology Research Center (N.N. Blokhin) Recruiting
Moscow, Russian Federation, 115478
Contact: Olga Yurievna Baranova    (925) 837-2708    baranova-crc@mail.ru   
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko Recruiting
Nizhniy Novgorod, Russian Federation, 603126
Contact: Olga S Samoilova, MD    +7(8) 312 38 93 ext 03      
Novosibirsk State Regional Clinical Hospital Recruiting
Novosibirsk, Russian Federation
Contact: Olga Alexandrovna Zhernosenko    (913) 783-4389      
Ryazan Regional Clinical Hospital Recruiting
Ryazan, Russian Federation, 390039
Contact: Alexander Pristupa, PHD, MD       alpristupa@mail.ru   
Samara Regional Clinical Hospital named after M.I. Kalinin Recruiting
Samara, Russian Federation, 443095
Contact: Viktor Rossiev, PHD       rossiev_v@mail.ru   
Saratov State Medical University Recruiting
Saratov, Russian Federation, 410028
Contact: Varvara Sergeevna Bogova    (927) 123-5077    bogova82@mail.ru   
Research Institute of Hematology and Blood Transfusion Recruiting
St. Petersburg, Russian Federation, 193024
Contact: Kudrat Abdulkadyrov, MD       haematology@atlant.ru   
Volgograd Regional Oncology Center #1 Recruiting
Volgograd, Russian Federation, 400138
Contact: Kamil D Kaplanov, PhD    +7(9) 272 57 68 ext 24    kamilos@mail.ru   
Spain
Hospital Universitario Germans Trias i Pujol Recruiting
Badalona, Cataluña, Spain, 08916
Contact: Christelle Ferra i Col, MD    34934978987    cferra@iconcologia.net   
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Cataluña, Spain, 8041
Contact: Silvia Borrell    34935537142    SBorrell@santpau.cat   
Hospital Clinic de Barcelona Recruiting
Barcelona, Cataluña, Spain, 8036
Contact: Antonio De La Riva    34932279214    DELARIVA@clinic.ub.es   
Hospital 12 de Octubre Recruiting
Madrid, Madrid, Communidad de, Spain, 28041
Contact: Javier De La Serna    34913908413    drjdelaserna@gmail.com   
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Madrid, Communidad de, Spain, 28222
Contact: Ana Garranzo, Ana    34911917763      
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28033
Contact: Pilar Souviron    34915202441    Pilar.Souviron@tfscro.com   
Hospital J.M. Morales Meseguer Recruiting
Murcia, Spain, 30008
Contact: Jose Galvez    34968360969    josegalvez100@gmail.com   
Turkey
Ankara University Medical Faculty Recruiting
Ankara, Turkey, 6590
Contact: Onder Arslan, MD    90505502570    arslan@medicine.ankara.edu.tr   
Hacettepe University Medical Faculty Recruiting
Ankara, Turkey, 6100
Contact: Nilgun Sayinalp, MD    903123051543    nsayinal@hacettepe.edu.tr   
Gazi University Medical Faculty Gazi Hospital Recruiting
Ankara, Turkey, 06500
Contact: Yagci Munci, MD    +90 3122026317    ayagci@gazi.edu.tr   
Istanbul University Istanbul Medical Faculty Recruiting
Istanbul, Turkey, 34093
Contact: Melih Aktan, MD    902124142000    maktan@istanbul.edu.tr   
Erciyes University Medical Faculty Recruiting
Kayseri, Turkey, 38040
Contact: Mustafa Cetin    +903524374901 27030    mcetin@erciyes.edu.tr   
Ondokuz Mayis University Faculty of Medicine Recruiting
Samsun, Turkey, 55239
Contact: Mehmet Turgut, MD    (903) 623-1219 ext 19    turgutm@omu.edu.tr   
United Kingdom
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: James Whitehouse    +44(0)121 424 1075    james.whitehouse@heartofengland.nhs.uk   
Kent and Canterbury Hospital Recruiting
Canterbury, United Kingdom, CT1 3NG
Contact: Lavinia Parsons    +44(0)1227 864129    lavinia.parsons@nhs.net   
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: Sophie Norton    +44(0)2920 744147    Sophie.Norton@wales.nhs.uk   
Dorset County Hospital Recruiting
Dorchester, United Kingdom, DT1 2JY
Contact: Sally Love    +44(0)1305 255261    Sally.love@dchft.nhs.uk   
Northwick Park Hospital Recruiting
Harrow, United Kingdom, HA1 3UJ
Contact: Shelley Harvey    +44(0)208 869 5088    shelleyharvey1@nhs.net   
St James's University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Catherine Norton    +44(0)113 206 8577    catherine.norton@leedsth.nhs.uk   
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Tracey Wellman    +44(0)151 706 4889    Tracey.Wellman@rlbuht.nhs.uk   
Hammersmith Hospital Recruiting
London, United Kingdom, W12 0NN
Contact: Christos Paliompeis    +44(0)208 383 4715    c.paliompeis@imperial.ac.uk   
University College London Recruiting
London, United Kingdom, NW1 2PG
Contact: Joanna Calvert    (448) 451-5550 ext 0078260    joanna.calvert@uclh.nhs.uk   
Contact: Sharon Edleston    +44(0)845 1555000 ext 4184    Sharon.edleston@uclh.nhs.uk   
St Bartholomews Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Tobi Sogbanmu    +44(0)2034656758    tobi.sogbanmu@bartshealth.nhs.uk   
Sarah Cannon Research Institute UK Recruiting
London, United Kingdom, W1G 6AD
Contact: Joana Hauser    +44(0)203 219 5253    Joana.Hauser@HCAHealthcare.co.uk   
Contact: Mary-Jane Lauigan    +44(0)203 219 5218    MaryJane.Lauigan@HCAHealthcare.co.uk   
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Jen Lewis    +44(0)20 3299 5061    jen.lewis@nhs.net   
Contact: Jonathon Samuel    +44(0)203 299 5769    jonathon.samuel@nhs.net   
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Stephanie Manning    +44(0)161 918 7248    Stephanie.Manning@christie.nhs.uk   
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Richard Stanley    +44(0)115 9691169 ext 55702    richard.stanley@nuh.nhs.uk   
Churchill Hospital Recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Julia Laurence    +44(0)1865 572048    Julia.Laurence@ouh.nhs.uk   
Salisbury District Hospital Recruiting
Salisbury, United Kingdom, SP2 8BJ
Contact: Claire Smith    +44(0)1722 336262 x2103    claire.smith@salisbury.nhs.uk   
Great Western Hospital Recruiting
Swindon, United Kingdom, SN3 6BB
Contact: Tim Owen    +44(0)1793 604506    Tim.Owen@gwh.nhs.uk   
Torbay District General Hospital Recruiting
Torquay, United Kingdom, TQ2 7AA
Contact: Lyn Micklewright    +44(0)1803 656623    sdhct.cancertrialstorbay@nhs.net   
Contact: Lorraine Thornton    +44(0)1803 656624    lorraine.thornton@nhs.net   
Royal Cornwall Hospital Recruiting
Truro, United Kingdom, TR1 3LJ
Contact: Sophie Mepham    +44(0)1872 252527    sophie.mepham@rcht.cornwall.nhs.uk   
Contact: Bianca Mills    +44(0)1872 25 2527    Bianca.Mills@rcht.cornwall.nhs.uk   
New Cross Hospital Recruiting
Wolverhampton, United Kingdom, WV10 0QP
Contact: Claire Beardsmore    +44(0)1902 694430    claire.beardsmore@nhs.net   
Yeovil District Hospital Recruiting
Yeovil, United Kingdom, BA21 4AT
Contact: Nigel Beer    +44(0)1935 384798    Nigel.Beer@YDH.NHS.UK   
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thomas Jahn, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01569295     History of Changes
Other Study ID Numbers: GS-US-312-0115, 2011-006292-20
Study First Received: March 27, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
CLL
CAL 101
CAL-101
GS 1101
GS-1101
PI3K
Rituxan
Rituximab
Bendamustine
Leukemia
idelalisib

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Rituximab
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014