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Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela ) (Tugela)

Primary Purpose

Chronic Lymphocytic Leukemia

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

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Zydelig, CLL, CAL-101, GS 1101, GS-1101, PI3K, Rituxan, Rituximab, Bendamustine, Leukemia, idelalisib

Eligibility Criteria

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

Key Inclusion Criteria:

  • Previously treated recurrent CLL
  • Measurable lymphadenopathy
  • Requires therapy for CLL
  • Has experienced CLL progression < 36 months since the completion of the last prior therapy

Key Exclusion Criteria:

  • Recent history of a major non-CLL malignancy
  • Evidence of an ongoing infection
  • CLL refractory to bendamustine
  • Concurrent participation in another therapeutic clinical trial

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

Sites / Locations

  • Clearview Cancer Institute
  • UCLA Medical Center
  • Stanford Cancer Center
  • Rocky Mountain Cancer Center
  • University of Florida
  • Winship Cancer Institute at Emory University
  • Dana Farber Cancer Institute
  • University of Nebraska Medical Center
  • Summit Medical Group, P.A.
  • North Shore University Hospital
  • Long Island Jewish Medical Center
  • Memorial Sloan Kettering Cancer Center
  • Columbia University Medical Center
  • Willamette Valley Cancer Center
  • Charleston Hematology Oncology
  • Texas Oncology
  • Texas Oncology PA
  • Texas Oncology
  • University of Texas MD Anderson Cancer Center
  • Seattle Cancer Care Alliance
  • Cancer Care Northwest, US Oncology
  • Virginia Cancer Specialists, PC
  • Medical College of Wisconsin
  • St Vincent's Hospital - Sydney
  • Gosford Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • Monash Medical Centre - Clayton Campus
  • Sir Charles Gairdner Hospital
  • Princess Alexandra Hospital
  • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
  • UZ Gent
  • UZ Leuven
  • Cancer Care Manitoba
  • Clinical Hospital "Dubrava"
  • Klinichki Bolnicki Centar-Zagreb
  • University Hospital Merkur
  • Fakultni nemocnice Brno
  • Fakultní nemocnice Hradec Králové
  • Fakultni nemocnice Ostrava
  • Hopital Henri Mondor
  • Centre Jean Bernard - Clinique Victor Hugo
  • CHRU Lille-Hôpital Claude Huriez
  • Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
  • Centre Hospitalier de Mulhouse
  • CHU Hôtel-Dieu-Service Hématologie
  • Centre Hospitalier Lyon Sud
  • Hopital Purpan
  • Hôpitaux de Brabois
  • G. Genimatas Hospital
  • University General Hospital of Patras
  • Semmelweis Egyetem
  • Országos Onkológiai Intézet
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum
  • Tallian Gyula utca 20-32
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Mater Misericordiae Hospital
  • Spedali Civili di Brescia
  • Ospedale Oncologico Regionale A. Businco
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette
  • Szpital Specjalistyczny w Brzozowie
  • Malopolskie Centrum Medyczne
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny Nr 1
  • Wojewodzki Szpital w Opolu
  • Centralny Szpital Kliniczny MSW w Warszawie
  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
  • Hospital Santa Maria
  • "Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
  • Emergency County Clinical Hospital Brasov
  • "Colentina" Clinical Hospital
  • "Fundeni" Clinical Institute
  • Regional Oncology Institute Iasi
  • Russian Oncology Research Center (N.N. Blokhin)
  • Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
  • Novosibirsk State Regional Clinical Hospital
  • Ryazan Regional Clinical Hospital
  • Saratov State Medical University
  • Research Institute of Hematology and Blood Transfusion
  • State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital 12 de Octubre
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario de La Princesa
  • Gazi University Medical Faculty Gazi Hospital
  • Ankara University Medical Faculty
  • Istanbul University Istanbul Medical Faculty
  • Ondokuz Mayis University Faculty of Medicine
  • Birmingham Heartlands Hospital
  • Kent and Canterbury Hospital
  • University Hospital of Wales
  • Dorset County Hospital
  • St. James University Hospital
  • Royal Liverpool University Hospital
  • St Bartholomews Hospital
  • King's College Hospital
  • Hammersmith Hospital
  • University College London
  • Christie Hospital
  • Nottingham University Hospitals NHS Trust
  • Churchill Hospital
  • Royal Cornwall Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Idelalisib+bendamustine+rituximab

Placebo to match idelalisib+bendamustine+rituximab

Arm Description

Participants will receive idelalisib plus bendamustine and rituximab

Participants will receive placebo to match idelalisib plus bendamustine and rituximab

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.

Secondary Outcome Measures

Overall Response Rate (ORR)
ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
Lymph Node Response Rate
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Overall Survival
Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Complete Response Rate
Complete response (CR) rate was defined as the percentage of participants who achieved a CR.

Full Information

First Posted
March 27, 2012
Last Updated
March 2, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01569295
Brief Title
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Acronym
Tugela
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2012 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (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 effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Zydelig, CLL, CAL-101, GS 1101, GS-1101, PI3K, Rituxan, Rituximab, Bendamustine, Leukemia, idelalisib

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Idelalisib+bendamustine+rituximab
Arm Type
Experimental
Arm Description
Participants will receive idelalisib plus bendamustine and rituximab
Arm Title
Placebo to match idelalisib+bendamustine+rituximab
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to match idelalisib plus bendamustine and rituximab
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
GS-1101, CAL-101, Zydelig®
Intervention Description
Idelalisib 150 mg administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®, MabThera
Intervention Description
Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Ribomustin, Treanda®
Intervention Description
Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
Intervention Type
Drug
Intervention Name(s)
Placebo to match idelalisib
Intervention Description
Placebo to match idelalisib administered orally twice daily
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
Time Frame
Up to 84 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy. PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.
Time Frame
Up to 84 months
Title
Lymph Node Response Rate
Description
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Time Frame
Up to 84 months
Title
Overall Survival
Description
Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Time Frame
Up to 84 months
Title
Complete Response Rate
Description
Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
Time Frame
Up to 84 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Previously treated recurrent CLL Measurable lymphadenopathy Requires therapy for CLL Has experienced CLL progression < 36 months since the completion of the last prior therapy Key Exclusion Criteria: Recent history of a major non-CLL malignancy Evidence of an ongoing infection CLL refractory to bendamustine Concurrent participation in another therapeutic clinical trial 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
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94035
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Summit Medical Group, P.A.
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
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
Willamette Valley Cancer Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Texas Oncology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Cancer Care Northwest, US Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
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
Gosford Hospital
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre - Clayton Campus
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Clinical Hospital "Dubrava"
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinichki Bolnicki Centar-Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultni 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
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Hopital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Jean Bernard - Clinique Victor Hugo
City
Le Mans cedex
ZIP/Postal Code
72015
Country
France
Facility Name
CHRU Lille-Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59045
Country
France
Facility Name
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
CHU Hôtel-Dieu-Service Hématologie
City
Nantes
ZIP/Postal Code
44 093
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
Pierre Bénite
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpitaux de Brabois
City
Vandoeuvre-lés-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
G. Genimatas Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Tallian Gyula utca 20-32
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Mater Misericordiae Hospital
City
Dublin
Country
Ireland
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale Oncologico Regionale A. Businco
City
Cagliari
ZIP/Postal Code
9121
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Szpital Specjalistyczny w Brzozowie
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Malopolskie Centrum Medyczne
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Wojewodzki Szpital w Opolu
City
Opole
ZIP/Postal Code
43-372
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Emergency County Clinical Hospital Brasov
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
"Colentina" Clinical Hospital
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
"Fundeni" Clinical Institute
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Facility Name
Regional Oncology Institute Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Russian Oncology Research Center (N.N. Blokhin)
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novosibirsk State Regional Clinical Hospital
City
Novosibirsk
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Research Institute of Hematology and Blood Transfusion
City
St. Petersburg
ZIP/Postal Code
193024
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 Germans Trias i Pujol
City
Badalona
State/Province
Cataluña
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
8041
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
State/Province
Madrid, Communidad De
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid, Communidad De
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Gazi University Medical Faculty Gazi Hospital
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
6590
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Ondokuz Mayis University Faculty of Medicine
City
Samsun
ZIP/Postal Code
55239
Country
Turkey
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
St Bartholomews Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
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
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
Citation
Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.
Results Reference
background
Citation
Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.
Results Reference
background
Citation
Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.
Results Reference
background
Citation
Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA
Results Reference
background
PubMed Identifier
28139405
Citation
Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.
Results Reference
background
PubMed Identifier
31729982
Citation
Montillo M, Illes A, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.
Results Reference
derived

Learn more about this trial

Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

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