search
Back to results

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

Primary Purpose

Indolent Non-Hodgkin's Lymphomas

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Idelalisib
Rituximab
Bendamustine
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Non-Hodgkin's Lymphomas focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clearview Cancer Institute
  • Ironwood Cancer and Research Center
  • Comprehensive Blood and Cancer Center (Bakersfield)
  • Saint Jude Heritage Healthcare (TORI)
  • Pacific Shores Medical Group
  • Cancer Care Associates
  • San Luis Obispo Oncology and Hematology
  • Cancer Center of Santa Barbara
  • Central Coast Medical Oncology Group
  • St Joseph Heritage Healthcare System
  • Kaiser Permanente Vallejo Medical Center
  • Sylvester Comprehensive Cancer Center/UMHC
  • Cancer Specialists of North Florida
  • Northwest Georgia Oncology Centers, PC
  • Rush University Medical Center
  • Joliet Oncology Hematology Associates Ltd.
  • Cancer Center of Kansas
  • Rutgers Cancer Institute of New Jersey
  • North Shore Hematology/Oncology Associates
  • Weill Cornell Medical College
  • Signal Point Clinical Research Center, LLC
  • Hollings Cancer Center
  • Bon Secours Saint Francis Hospital
  • Texas Oncology, P.A.
  • Charles A. Sammons Cancer Center
  • Texas Oncology, P.A.
  • Brooke Army Medical Center
  • Texas Oncology, P.A.
  • Texas Oncology, P.A.
  • Swedish Medical Center
  • Northwest Medical Specialists
  • Aurora BayCare Medical Center
  • Froedtert Hospital and Medical College of Wisconsin
  • Prince of Wales Hospital
  • Haematology and Oncology Clinics of Australia Gold Coast
  • Royal Adelaide Hospital
  • Adelaide Cancer Centre
  • Box Hill Hospital
  • Monash Medical Centre
  • Saint Vincent's Hospital
  • Western Hospital
  • Royal Perth Hospital
  • Tom Baker Cancer Center
  • Cross Cancer Institute
  • Fraser Clinical Trials, Inc.
  • BC Cancer Agency - Vancouver Centre
  • Queen Elizabeth II Health Sciences Centre, Centre for Clinical Research
  • Royal Victoria Regional Health Centre
  • Sunnybrook Health Sciences Centre
  • Hôpital Charles Lemoyne
  • McGill University Health Centre
  • Centre Hospitalier Universitaire de Sherbrooke
  • Centre Hospitalier Affilie Universitaire de Quebec
  • CancerCare Manitoba
  • Fakultní Nemocnice Ostrava
  • Fakultní nemocnice Brno
  • Fakultní nemocnice Hradec Králové
  • CHR Metz
  • Centre Hospitalier Universitaire de Strasbourg - Hôpital Hautepierre
  • Institut Bergonié
  • Centre Henri-Becquerel
  • Hôpital Necker-Enfants Malades
  • Centre Jean Bernard
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire Brest
  • Centre Hospitalier de Dunkerque
  • Centre Hospitalier Départmental La Roche sur Yon
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • Hôpital Hôtel-Dieu
  • Centre Hospitalier Universitaire de Poitiers
  • Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
  • Institut Gustave Roussy
  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
  • Gemeinschaftspraxis Dres. Söling Und Siehl
  • Vivantes Klinikum am Urban
  • Charite - Campus Virchow
  • Klinikum der Ludwig-Maximilians-Universität München
  • Barzilai Medical Center
  • Soroka University Medical Center
  • Rambam Health Corp.
  • Hadassah Medical Organization, Ein Kerem
  • Centro di Riferimento Oncologico di Aviano
  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Spedali Civili Di Brescia Azienda Ospedaliera
  • IRCCS Azienda Ospedaliera Universitaria San Martino
  • Ospedale San Raffaele-IRCCS
  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  • Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto
  • Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • Dong-A University Medical Center
  • Seoul National University Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Uniwersyteckie Centrum Kliniczne
  • Malopolskie Centrum Medyczne S.C.
  • Szpital Kliniczny nr 1, Katedra i Klinika Hematoonkologii i Transplantacji Szpiku
  • Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Instytut Hematologii i Transfuzjologii
  • Centrum Onkologii i Hipertermii
  • Sverdlovsk Regional Clinical Hospital #1
  • Central City Hospital # 7
  • N. N. Blokhin Russian Cancer Research Center
  • Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
  • Ryazan Regional Clinical Hospital
  • FGU Russian Scientific Research Institute of Hematology and Transfusiology
  • FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"
  • Saint Petersburg I.P. Pavlov State Medical University
  • Saratov State Medical University
  • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario La Princesa
  • Hospital General Universitario Gregorio Marañon
  • Hospital Clínico Universitario de Salamanca
  • Hospital Universitario de Canarias
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitari i Politecnic La Fé de Valencia
  • Karolinska Universitetssjukhuset
  • Länssjukhuset Ryhov
  • Changhua Christian Hospital
  • China Medical University Hospital
  • National Cheng-Kung University Hospital
  • National Taiwan University Hospital
  • Kent and Canterbury Hospital
  • University Hospital Coventry
  • Royal Bournemouth General Hospital
  • Leeds Teaching Hospitals NHS Trust
  • Barts and The London NHS Trust
  • University College London Hospitals National Health Society Foundation Trust
  • Guys and Saint Thomas NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • Maidstone Hospital
  • Christie Hospital NHS Foundation Trust
  • Oxford University Hospitals NHS Trust
  • Southampton General Hospital
  • Mount Vernon Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rituximab + Bendamustine + Idelalisib

Rituximab + Bendamustine + Placebo

Arm Description

Participants will receive rituximab + bendamustine + idelalisib.

Participants will receive rituximab + bendamustine + placebo.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
November 14, 2012
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01732926
Brief Title
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Acronym
Bridalveil
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
January 2, 2013 (Actual)
Primary Completion Date
May 17, 2016 (Actual)
Study Completion Date
May 17, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Non-Hodgkin's Lymphomas
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
475 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab + Bendamustine + Idelalisib
Arm Type
Experimental
Arm Description
Participants will receive rituximab + bendamustine + idelalisib.
Arm Title
Rituximab + Bendamustine + Placebo
Arm Type
Experimental
Arm Description
Participants will receive rituximab + bendamustine + placebo.
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig®, CAL-101, GS-1101
Intervention Description
150 mg tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®, MabThera®
Intervention Description
375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda®
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet administered orally twice daily
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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 Measure Information:
Title
Complete Response Rate (CR)
Description
Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
Title
Overall Response Rate (ORR)
Description
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.
Title
Lymph Node Response Rate
Description
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.
Title
Overall Survival (OS)
Description
Overall survival is defined as the interval from randomization to death from any cause.

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency

Learn more about this trial

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

We'll reach out to this number within 24 hrs