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Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Bridalveil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732926
Recruitment Status : Terminated
First Posted : November 26, 2012
Results First Posted : May 11, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/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).


Condition or disease Intervention/treatment Phase
Indolent Non-Hodgkin's Lymphomas Drug: Idelalisib Drug: Rituximab Drug: Bendamustine Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Indolent Non-Hodgkin Lymphomas
Actual Study Start Date : January 2, 2013
Actual Primary Completion Date : May 17, 2016
Actual Study Completion Date : May 17, 2016


Arm Intervention/treatment
Experimental: Rituximab + Bendamustine + Idelalisib
Participants will receive rituximab + bendamustine + idelalisib.
Drug: Idelalisib
150 mg tablet administered orally twice daily
Other Names:
  • Zydelig®
  • CAL-101
  • GS-1101

Drug: Rituximab
375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Other Names:
  • Rituxan®
  • MabThera®

Drug: Bendamustine
90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Other Name: Treanda®

Experimental: Rituximab + Bendamustine + Placebo
Participants will receive rituximab + bendamustine + placebo.
Drug: Rituximab
375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Other Names:
  • Rituxan®
  • MabThera®

Drug: Bendamustine
90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Other Name: Treanda®

Drug: Placebo
Tablet administered orally twice daily




Primary Outcome Measures :
  1. Progression-free Survival (PFS)
    PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).


Secondary Outcome Measures :
  1. Complete Response Rate (CR)
    Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.

  2. Overall Response Rate (ORR)
    Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.

  3. Lymph Node Response Rate
    Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.

  4. Overall Survival (OS)
    Overall survival is defined as the interval from randomization to death from any cause.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

    1. Follicular lymphoma (FL) Grade 1, 2, or 3a
    2. Small lymphocytic lymphoma (SLL)
    3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
    4. 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.
  • Prior treatment with bendamustine that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732926


Locations
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United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
United States, Arizona
Ironwood Cancer and Research Center
Chandler, Arizona, United States, 85224
United States, California
Comprehensive Blood and Cancer Center (Bakersfield)
Bakersfield, California, United States, 93309
Saint Jude Heritage Healthcare (TORI)
Fullerton, California, United States, 92835
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Cancer Care Associates
Redondo Beach, California, United States, 90277
San Luis Obispo Oncology and Hematology
San Luis Obispo, California, United States, 93401
Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Group
Santa Maria, California, United States, 93454
St Joseph Heritage Healthcare System
Santa Rosa, California, United States, 95403
Kaiser Permanente Vallejo Medical Center
Vallejo, California, United States, 94589
United States, Florida
Sylvester Comprehensive Cancer Center/UMHC
Deerfield Beach, Florida, United States, 33442
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
United States, Georgia
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Joliet Oncology Hematology Associates Ltd.
Joliet, Illinois, United States, 60435
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
North Shore Hematology/Oncology Associates
East Setauket, New York, United States, 11733
Weill Cornell Medical College
New York, New York, United States, 10065
United States, Ohio
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States, 45042
United States, South Carolina
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Bon Secours Saint Francis Hospital
Greenville, South Carolina, United States, 29607
United States, Texas
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology, P.A.
Denton, Texas, United States, 76210
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Texas Oncology, P.A.
Harlingen, Texas, United States, 78550-8321
Texas Oncology, P.A.
Weslaco, Texas, United States, 78596-6608
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Northwest Medical Specialists
Tacoma, Washington, United States, 98405
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54308
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Haematology and Oncology Clinics of Australia Gold Coast
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Saint Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Western Hospital
Footscray, Victoria, Australia, 3011
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Canada, Alberta
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 2T9
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Fraser Clinical Trials, Inc.
New Westminster, British Columbia, Canada, V3L 3W4
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada, L4M 6M2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hôpital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
McGill University Health Centre
Montréal, Quebec, Canada, H4A 3JI
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Centre Hospitalier Affilie Universitaire de Quebec
Quebec, Canada, G1J 1Z4
CancerCare Manitoba
Winnipeg, Canada, R3E 0V9
Czechia
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky KRAJ, Czechia, 708 52
Fakultní nemocnice Brno
Brno, Czechia, 625 00
Fakultní nemocnice Hradec Králové
Hradec Králové, Czechia, 500 05
France
CHR Metz
Metz Cedex 03, Alsace, France, 57085
Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
Strasbourg Cedex, Alsace, France, 67098
Institut Bergonié
Bordeaux Cedex, Aquitaine, France, 33076
Centre Henri-Becquerel
Rouen Cedex 1, Haute-normandie, France, 76038
Hôpital Necker-Enfants Malades
Paris, Ile-de-france, France, 75015
Centre Jean Bernard
Le Mans, PAYS DE LA Loire, France, 72000
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex, Rhone-alpes, France, 69495
Centre Hospitalier Universitaire Brest
Brest Cedex, France, 29609
Centre Hospitalier de Dunkerque
Dunkerque, France, 59385
Centre Hospitalier Départmental La Roche sur Yon
La Roche sur Yon, France, 85925
Centre Léon Bérard
Lyon Cedex 08, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
Hôpital Hôtel-Dieu
Nantes cedex 1, France, 44093
Centre Hospitalier Universitaire de Poitiers
Poitiers Cedex, France, 86021
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, 94805
Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Baden-wuerttemberg, Germany, 78054
Gemeinschaftspraxis Dres. Söling Und Siehl
Kassel, Hessen, Germany, 34117
Vivantes Klinikum am Urban
Berlin, Germany, 10967
Charite - Campus Virchow
Berlin, Germany, 13353
Klinikum der Ludwig-Maximilians-Universität München
München, Germany, 81377
Israel
Barzilai Medical Center
Ashkelon, Israel, 78278
Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Health Corp.
Haifa, Israel, 31096
Hadassah Medical Organization, Ein Kerem
Jerusalem, Israel, 91120
Italy
Centro di Riferimento Oncologico di Aviano
Aviano, Italy, 33081
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Spedali Civili Di Brescia Azienda Ospedaliera
Brescia, Italy, 25123
IRCCS Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Ospedale San Raffaele-IRCCS
Milano, Italy, 20132
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milano, Italy, 20162
Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
Novara, Italy, 28100
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Italy, 61122
Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
Piacenza, Italy, 29100
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, Italy, 53100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Korea, Republic of
Dong-A University Medical Center
Busan, Korea, Republic of, 602-715
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Malopolskie Centrum Medyczne S.C.
Kraków, Poland, 30-510
Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, Poland, 20-081
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
Lódz, Poland, 93-510
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
Olsztyn, Poland, 10-228
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
Slupsk, Poland, 76-200
Centralny Szpital Kliniczny MSW w Warszawie
Warszawa, Poland, 02-507
Instytut Hematologii i Transfuzjologii
Warszawa, Poland, 02-776
Centrum Onkologii i Hipertermii
Warszawa, Poland, 02-781
Russian Federation
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, Russian Federation, 620102
Central City Hospital # 7
Ekaterinburg, Russian Federation, 620137
N. N. Blokhin Russian Cancer Research Center
Moscow, Russian Federation, 115478
Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
Nizhniy Novgorod, Russian Federation, 603126
Ryazan Regional Clinical Hospital
Ryazan, Russian Federation, 390039
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg, Russian Federation, 191024
FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
Saint Petersburg, Russian Federation, 197341
Saint Petersburg I.P. Pavlov State Medical University
Saint-Petersburg, Russian Federation, 197022
Saratov State Medical University
Saratov, Russian Federation, 140012
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
Volgograd, Russian Federation, 400138
Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Clínico Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Universitario de Canarias
San Cristobal de La Laguna, Spain, 38320
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitari i Politecnic La Fé de Valencia
Valencia, Spain, 46026
Sweden
Karolinska Universitetssjukhuset
Huddinge, Stockholm, Sweden, 141 86
Länssjukhuset Ryhov
Jönköping, Sweden, 551 85
Taiwan
Changhua Christian Hospital
Changhua city, Taiwan, 500
China Medical University Hospital
Taichung, Taiwan, 404
National Cheng-Kung University Hospital
Tainan, Taiwan, 70403
National Taiwan University Hospital
Taipei, Taiwan, 10002
United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
University Hospital Coventry
Coventry, England, United Kingdom, CV2 2DX
Royal Bournemouth General Hospital
Dorset, England, United Kingdom, BH7 7DW
Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom, LS9 7TF
Barts and The London NHS Trust
London, England, United Kingdom, EC1M 6BQ
University College London Hospitals National Health Society Foundation Trust
London, England, United Kingdom, NW1 2PG
Guys and Saint Thomas NHS Foundation Trust
London, England, United Kingdom, SE1 9RT
Imperial College Healthcare NHS Trust
London, England, United Kingdom, W12 0NN
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital NHS Foundation Trust
Manchester, England, United Kingdom, M20 4BX
Oxford University Hospitals NHS Trust
Oxford, England, United Kingdom, OX3 7LE
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Mount Vernon Hospital
Middlesex, United Kingdom, HA6 2RN
New Cross Hospital
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01732926    
Other Study ID Numbers: GS-US-313-0125
2012-004034-42 ( EudraCT Number )
First Posted: November 26, 2012    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: November 16, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gilead Sciences:
iNHL
indolent NHL
follicular lymphoma
CAL-101
rituximab
bendamustine
small lymphocytic lymphoma
lymphoplasmacytoid lymphoma
Waldenstrom macroglobulinemia
LPL
WM
Marginal zone lymphoma
MZL
SLL
FL
GS-1101
PI3K inhibitor
idelalisib
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Idelalisib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors