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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01569295
First received: March 27, 2012
Last updated: September 5, 2014
Last verified: September 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 to match idelalisib
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: Up to 30 months ] [ 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: Up to 30 months ] [ 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: Up to 30 months ] [ 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 lesions.

  • Overall Survival [ Time Frame: Up to 30 months ] [ 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: Up to 30 months ] [ 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
Experimental: Idelalisib+bendamustine+rituximab
Participants will receive idelalisib plus bendamustine and rituximab for up to 30 months.
Drug: Idelalisib
Idelalisib 150 mg administered orally twice daily
Other Names:
  • GS-1101
  • CAL 101
  • CAL-101
  • Zydelig®
Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Other Names:
  • Rituxan®
  • MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Other Names:
  • Ribomustin
  • Treanda®
  • SDX-105
Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab
Participants will receive placebo to match idelalisib plus bendamustine and rituximab for up to 30 months.
Drug: Rituximab
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Other Names:
  • Rituxan®
  • MabThera
Drug: Bendamustine
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Other Names:
  • Ribomustin
  • Treanda®
  • SDX-105
Drug: Placebo to match idelalisib
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

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, California
Stanford Cancer Center
Palo Alto, California, United States, 94304
UCLA Medical Center
Santa Monica, California, United States, 90404
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
United States, Georgia
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Hematology Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11042
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97225
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29414
United States, Texas
Texas Oncology
Austin, Texas, United States, 78731
Texas Oncology PA
Dallas, Texas, United States, 78246
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Cancer Care Northwest, US Oncology
Spokane, Washington, United States, 99202
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Instituto de Hematologia y Medicina Clinica "Dr. Ruben Davoli"
Rosario, Argentina, 2000
Australia, New South Wales
St Vincent's Hospital - Sydney
Darlinghurst, New South Wales, Australia, 2010
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Monash Medical Centre - Clayton Campus
Clayton, Victoria, Australia, 3168
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Australia
Princess Alexandra Hospital
Woolloongabba, Australia, 4102
Belgium
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
Antwerpen, Belgium, 2060
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Croatia
Clinical Hospital "Dubrava"
Zagreb, Croatia, 10000
Klinichki Bolnicki Centar-Zagreb
Zagreb, Croatia, 10000
University Hospital Merkur
Zagreb, Croatia, 10000
Czech Republic
Fakultni nemocnice Brno
Brno, Czech Republic, 625 00
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Czech Republic, 500 05
Fakultni nemocnice Ostrava
Ostrava, Czech Republic, 708 52
France
Hôpital Henri Mondor
Creteil, France, 94010
Centre Jean Bernard - Clinique Victor Hugo
Le Mans cedex, France, 72015
CHRU Lille-Hôpital Claude Huriez
Lille, France, 59045
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
Lyon, France, 69373
Centre Hospitalier de Mulhouse
Mulhouse, France, 68100
CHU Hôtel-Dieu-Service Hématologie
Nantes, France, 44 093
Hopital Cochin
Paris, France, 75104
Centre Hospitalier Lyon Sud
Pierre Bénite, France, Pierre Bénite
Hopital Purpan
Toulouse, France, 31059
Hôpitaux de Brabois
Vandoeuvre-lés-Nancy, France, 54511
Greece
G. Genimatas Hospital
Athens, Greece, 11527
University General Hospital of Patras
Patras, Greece, 26500
Hungary
Országos Onkológiai Intézet
Budapest, Hungary, 1122
Semmelweis Egyetem
Budapest, Hungary, 1083
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, Hungary, 4032
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, Hungary, 7400
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Hungary, 6720
Ireland
Mater Misericordiae Hospital
Dublin, Ireland
Italy
Spedali Civili di Brescia
Brescia, Italy, 25123
Ospedale Oncologico Regionale A. Businco
Cagliari, Italy, 9121
Azienda Ospedaliera Niguarda Ca Granda
Milano, Italy, 20162
O Spedale San Rafaelle S.r.l.
Milano, Italy, 20132
Policlinico Universitario "A. Gemelli"
Roma, Italy, 00168
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
New Zealand
Wellington Hospital
Wellington South, New Zealand
Poland
Szpital Specjalistyczny w Brzozowie
Brzozow, Poland, 36-200
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland, 20-081
Wojewodzki Szpital w Opolu
Opole, Poland, 43-372
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa, Poland, 02-507
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Portugal
Hospital Santa Maria
Lisboa, Portugal, 1649-035
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
Porto, Portugal, 4200-072
Romania
Emergency County Clinical Hospital Brasov
Brasov, Romania, 500326
"Colentina" Clinical Hospital
Bucharest, Romania
"Fundeni" Clinical Institute
Bucharest, Romania, 22328
Regional Oncology Institute Iasi
Iasi, Romania, 700483
Russian Federation
Russian Oncology Research Center (N.N. Blokhin)
Moscow, Russian Federation, 115478
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod, Russian Federation, 603126
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russian Federation
Ryazan Regional Clinical Hospital
Ryazan, Russian Federation, 390039
Saratov State Medical University
Saratov, Russian Federation, 410028
Research Institute of Hematology and Blood Transfusion
St. Petersburg, Russian Federation, 193024
Volgograd Regional Oncology Center #1
Volgograd, Russian Federation, 400138
Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Cataluña, Spain, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Cataluña, Spain, 8041
Hospital Clinic de Barcelona
Barcelona, Cataluña, Spain, 8036
Hospital 12 de Octubre
Madrid, Madrid, Communidad de, Spain, 28041
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Communidad de, Spain, 28222
Hospital Universitario de La Princesa
Madrid, Spain, 28033
Turkey
Ankara University Medical Faculty
Ankara, Turkey, 6590
Gazi University Medical Faculty Gazi Hospital
Ankara, Turkey, 06500
Istanbul University Istanbul Medical Faculty
Istanbul, Turkey, 34093
Ondokuz Mayis University Faculty of Medicine
Samsun, Turkey, 55239
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Kent and Canterbury Hospital
Canterbury, United Kingdom, CT1 3NG
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Dorset County Hospital
Dorchester, United Kingdom, DT1 2JY
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Hammersmith Hospital
London, United Kingdom, W12 0NN
St Bartholomews Hospital
London, United Kingdom, EC1A 7BE
University College London
London, United Kingdom, NW1 2PG
King's College Hospital
London, United Kingdom, SE5 9RS
Christie Hospital
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG51PB
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Royal Cornwall Hospital
Truro, United Kingdom, TR1 3LJ
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
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: September 5, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014