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Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

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

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

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

Key Inclusion Criteria:

  • Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
  • No prior therapy for CLL other than corticosteroids for disease complications
  • CLL that warrants treatment
  • Presence of measurable lymphadenopathy
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

  • Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
  • Known presence of myelodysplastic syndrome
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
  • Ongoing liver injury
  • History of non-infectious pneumonitis
  • Ongoing inflammatory bowel disease
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy other than corticosteroids
  • Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

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

Sites / Locations

  • St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
  • UCSD Moores Cancer Center
  • Central Coast Medical Oncology
  • Georgetown University
  • Memorial Healthcare System
  • Cancer Specialists of North Florida
  • Florida Cancer Specialists-South
  • Franciscan Physician Network Oncology & Hematology
  • Siouxland Hematology-Oncology Associates, LLP
  • Center for Cancer and Blood Disorders
  • Comprehensive Cancer Centers of Nevada
  • Hematology /Oncology Associates of Northern New Jersey
  • Columbia University Medical Center
  • University of Rochester
  • Gabrail Cancer Center Research
  • Sarah Cannon Research Institute
  • Signal Point Clinical Research Center
  • Saint Francis Hospital
  • Sarah Cannon Research Institute
  • Texas Oncology-Austin Midtown
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
  • Utah Cancer Specialists
  • Fred Hutchinson Cancer Research Center
  • St Vincent's Hospital, Sydney
  • Jarrett Street Specialist Centre
  • Calvary Mater Newcastle
  • Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
  • Flinders Medical Centre, Department of Haematology, Level 6
  • Ashford Cancer Centre Research
  • Queen Elizabeth Hospital
  • Frankston Hospital
  • Barwon Health, University Hospital Geelong
  • Z N A Stuivenberg
  • AZ Sint-Jan AV Brugge-Oostende
  • University Hospital Leuven
  • Cancercare Manitoba - Maccharles Unit
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Hôpital du Sacré-Coeur de Montréal
  • CHU de Québec - Hôpital de l'Enfant-Jésus
  • Klinicka bolnica Dubrava
  • Klinicka bolnica Merkur
  • UHC Zagreb
  • Faculty hospital Ostrava
  • University Hospital
  • Faculty Hospital Hradec Kralove
  • Faculty Hospital Plzen
  • Faculty Hospital Kralovske Vinohrady
  • CHRU de Lille, Hopital Claude Huriez
  • Hospital Saint-Louis
  • CHU Bretonneau
  • Szent Borbála Hospital
  • Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,
  • Semmelweis University
  • National Institute of Oncology
  • University of Debrecen HSC Institute of internal Medicine, Department of Hematology
  • Pandy Kalman Hospital
  • University Of Pecs, Medical School
  • Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika
  • IRCCS Istituto Tumori
  • Ospedale Oncologico Armando Businco
  • Ospedale San Raffaele
  • Azienda Ospedaliero Universitaria Policlinico di Modena
  • AOU Maggiore della Carità
  • Uniwersyteckie Centrum Kliniczne
  • Malopolskie Centrum Medyczne s.c.
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii
  • Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii
  • Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
  • Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku
  • Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
  • Emergency County Clinical Hospital Brasov
  • Spitalul Clinic Colentina
  • Hospital Vall de Hebron
  • Hospital Clinic
  • Hospital de la Santa Creu i Sant Pau
  • ICO, Hospitalet de Llobregat
  • Hospital Universitario La Princesa
  • Hospital Gregorio Marañon
  • Hospital Universitario Ramón Y Cajal
  • Hospital 12 de Octubre
  • Hospital Universitario Puerta De Hierro
  • University College London
  • East Kent Hospitals University NHS Foundation Trust
  • Royal Marsden NHS Trust
  • University Hospital of Wales
  • Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust
  • Hammersmith Hospitals NHS Trust
  • Oxford University Hospitals
  • University Hospital Southampton NHS Trust
  • Royal Wolverhampton Hospital NHS Trust, New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Idelalisib+bendamustine+rituximab

Placebo+bendamustine+rituximab

Arm Description

Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Outcomes

Primary Outcome Measures

Progression-Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).

Secondary Outcome Measures

Overall Response Rate
Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
Nodal Response Rate
Nodal 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 of index lesions. Nodal response rate was to be assessed by an IRC.
Complete Response Rate
Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Overall Survival
Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Minimal Residual Disease Negativity Rate at Week 36
Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.

Full Information

First Posted
November 5, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01980888
Brief Title
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
June 16, 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 progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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
Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Idelalisib+bendamustine+rituximab
Arm Type
Experimental
Arm Description
Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Arm Title
Placebo+bendamustine+rituximab
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig®, GS-1101, CAL-101
Intervention Description
150 mg tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Intervention Description
Administered intravenously at a starting dose of 90 mg/m^2 for up to 6 cycles. Dosing will be based on mg/m^2 of body surface area.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Single-use vials administered intravenously weekly starting at 375 mg/m^2 on Day 1 (Week 0) and 500 mg/m^2 thereafter for a total of 6 infusions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match idelalisib administered orally twice daily
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
Time Frame
Up to 22 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
Time Frame
Up to 22 months
Title
Nodal Response Rate
Description
Nodal 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 of index lesions. Nodal response rate was to be assessed by an IRC.
Time Frame
Up to 22 months
Title
Complete Response Rate
Description
Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
Time Frame
Up to 22 months
Title
Overall Survival
Description
Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
Time Frame
Up to 22 months
Title
Minimal Residual Disease Negativity Rate at Week 36
Description
Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.
Time Frame
Up to 22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) No prior therapy for CLL other than corticosteroids for disease complications CLL that warrants treatment Presence of measurable lymphadenopathy Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 Key Exclusion Criteria: Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation) Known presence of myelodysplastic syndrome Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization Ongoing liver injury History of non-infectious pneumonitis Ongoing inflammatory bowel disease History of prior allogeneic bone marrow progenitor cell or solid organ transplantation Ongoing immunosuppressive therapy other than corticosteroids Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization 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
St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Florida Cancer Specialists-South
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Facility Name
Franciscan Physician Network Oncology & Hematology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
Hematology /Oncology Associates of Northern New Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology-Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
St Vincent's Hospital, Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Jarrett Street Specialist Centre
City
North Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Flinders Medical Centre, Department of Haematology, Level 6
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Barwon Health, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Z N A Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint-Jan AV Brugge-Oostende
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cancercare Manitoba - Maccharles Unit
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C9
Country
Canada
Facility Name
Hôpital du Sacré-Coeur de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
CHU de Québec - Hôpital de l'Enfant-Jésus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Klinicka bolnica Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinicka bolnica Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
UHC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Faculty hospital Ostrava
City
Ostrava-Poruba
State/Province
Moravian-Silesian
ZIP/Postal Code
70852
Country
Czechia
Facility Name
University Hospital
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Faculty Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Faculty Hospital Plzen
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Prague 10
ZIP/Postal Code
10034
Country
Czechia
Facility Name
CHRU de Lille, Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hospital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
CHU Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Szent Borbála Hospital
City
Tatabánya
State/Province
Komárom - Esztergom
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Kaposi Mor Oktato Korhaz, Intezeti Gyogyszertar,
City
Kaposvar
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
National Institute of Oncology
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
University of Debrecen HSC Institute of internal Medicine, Department of Hematology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pandy Kalman Hospital
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
University Of Pecs, Medical School
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem AOK - Szent-Gyorgyi Albert Klinikai Kozpont, II. Belgyógyászati Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
IRCCS Istituto Tumori
City
Bari
State/Province
Puglia
ZIP/Postal Code
70024
Country
Italy
Facility Name
Ospedale Oncologico Armando Businco
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
AOU Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Malopolskie Centrum Medyczne s.c.
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika Klinika Hematologii
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie Klinika Onkologii i Hematologii
City
Warsaw
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Onkologii-Instytut Marii Sklodowskiej -Curie klinika Nowotworow Ukladu Chlonnego
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu Klinika i Katedra Hematologii,Nowotworow Krwi i Transplantacji Szpiku
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Emergency County Clinical Hospital Brasov
City
Brasov
ZIP/Postal Code
500326
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
Hospital Vall de Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Facility Name
ICO, Hospitalet de Llobregat
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
University College London
City
London
State/Province
England
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Royal Liverpool & Broadgreen Univ. Hospitals NHS Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Hammersmith Hospitals NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Oxford University Hospitals
City
Oxford
ZIP/Postal Code
OX37LE
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Wolverhampton Hospital NHS Trust, 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 in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

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