Back to resultsEfficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Yosemite)
Primary Purpose
Indolent Non-Hodgkin's Lymphomas
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Rituximab
Idelalisib
Sponsored by
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, Small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenstrom macroglobulinemia, LPL, WM, Marginal zone lymphoma, MZL, SLL, FL, GS-1101, idelalisib
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) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
- 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.
- Received previous treatment with rituximab that was not effective.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Clearview Cancer Institute
- Ironwood Cancer and Research Center
- City of Hope Cancer Center
- Saint Jude Heritage Healthcare
- Pacific Shores Medical Group
- UCLA Medical Center
- Cancer Care Associates
- Cancer Center of Santa Barbara
- Central Coast Medical Oncology Group
- Middlesex Hospital Cancer Center
- Georgetown University Medical Center
- Florida Cancer Specialists and Research Institute
- Moffitt Cancer Center
- Cancer Center of Kansas
- Wayne State University
- Comprehensive Cancer Centers of Nevada
- Montefiore Medical Center
- Icahn School of Medicine at Mount Sinai
- Weill Cornell Medical College
- MetroHealth Medical Center
- Signal Point Clinical Research Center, LLC
- Perelman Center for Advanced Medicine
- Prairie Lakes Healthcare System
- Tennessee Oncology, PLLC
- Sarah Cannon Cancer Center
- Texas Oncology, P.A.
- Brooke Army Medical Center
- Center for Cancer and Blood Disorders, PC
- Shenandoah Oncology Associates, PC
- Virginia Mason Medical Center
- Northwest Medical Specialties, PLLC
- Froedtert Hospital and Medical College of Wisconsin
- Haematology and Oncology Clinics of Australia at Chermside
- Box Hill Hospital
- Monash Medical Centre
- Saint Vincent's Hospital
- Western Hospital
- Royal Perth Hospital
- Adelaide Cancer Centre
- Fiona Stanley Hospital
- Fakultní nemocnice Hradec Králové
- University Hospital of Bordeaux
- Hôpital Necker-Enfants Malades
- Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
- Centre Hospitalier Universitaire Brest
- Centre Hospitalier de Dunkerque
- Centre Hospitalier de Versailles
- Centre Léon Bérard
- Hôpital Hôtel-Dieu
- Centre Hospitalier Lyon Sud
- Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
- Gemeinschaftspraxis Dres. Söling Und Siehl
- Debreceni Egyetem Orvos-és Egészségtudományi Centrum
- Somogy Megyei Kaposi Mór Oktató Kórház
- Markusovszky Egyetemi Oktatókórház
- Semmelweis Egyetem
- Országos Onkológiai Intézet
- Hadassah Medical Organization, Ein Kerem
- Rabin Medical Center
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Centro di Riferimento Oncologico di Aviano
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Nagoya City University Hospital
- National Hospital Organization Nagoya Medical Center
- Aichi Cancer Center Hospital
- National Hospital Organization Kyushu Cancer Center
- Kobe City Medical Center General Hospital
- Tokai University Hospital
- National Hospital Organization Kumamoto Medical Center
- Tohoku University Hospital
- Okayama University Hospital
- Osaka City University Hospital
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- Toranomon Hospital
- Seoul National University Hospital
- Samsung Medical Center
- Asan Medical Center
- Malopolskie Centrum Medyczne S.C.
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim
- Centrum Onkologii i Hipertermii
- Hospital Geral de Santo António do Centro Hospitalar do Porto
- Institutul Clinic Fundeni
- Sverdlovsk Regional Clinical Hospital #1
- Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko
- Ryazan Regional Clinical Hospital
- 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
- Singapore General Hospital
- National Cancer Centre Singapore
- Gleneagles Medical Centre
- Hospital Universitario Puerta de Hierro
- Hospital Universitari Germans Trias i Pujol
- Skånes Universitetssjukhus, Malmö
- Chang Gung Memorial Hospital (CGMH)
- Tri-Service General Hospital
- Barts and The London NHS Trust
- Mount Vernon Hospital
- Sunderland Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rituximab + idelalisib
Rituximab + Placebo
Arm Description
Participants will receive rituximab + idelalisib.
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Outcomes
Primary Outcome Measures
Progression Free Survival
Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. 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 complete response or partial response (or very good partial response or minor response 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.
Complete Response Rate
Complete response rate is defined as the proportion of participants who achieve a 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01732913
Brief Title
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Acronym
Yosemite
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 16, 2013 (Actual)
Primary Completion Date
May 18, 2016 (Actual)
Study Completion Date
May 18, 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 effect of the addition of idelalisib to 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, Small lymphocytic lymphoma, lymphoplasmacytoid lymphoma, Waldenstrom macroglobulinemia, LPL, WM, Marginal zone lymphoma, MZL, SLL, FL, GS-1101, idelalisib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab + idelalisib
Arm Type
Experimental
Arm Description
Participants will receive rituximab + idelalisib.
Arm Title
Rituximab + Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive rituximab + placebo. Following confirmation of iNHL disease progression by the independent review committee and unblinding, participants may be eligible to receive open-label idelalisib 150 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®, MabThera®
Intervention Description
375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
GS-1101, CAL-101, Zydelig®
Intervention Description
150 mg tablets 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 earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response 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
Complete Response Rate
Description
Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.
Title
Overall Survival
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) with absolute lymphocyte count < 5 x 10^9/L at the time of diagnosis
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.
Received previous treatment with rituximab 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
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Saint Jude Heritage Healthcare
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
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cancer Care Associates
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
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
Middlesex Hospital Cancer Center
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169-3321
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
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
Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Prairie Lakes Healthcare System
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57252
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology, P.A.
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
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
Center for Cancer and Blood Disorders, PC
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Shenandoah Oncology Associates, PC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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
Haematology and Oncology Clinics of Australia at Chermside
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
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
Adelaide Cancer Centre
City
Kurralta Park
ZIP/Postal Code
SA 5037
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Fakultní nemocnice Hradec Králové
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital of Bordeaux
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez
City
Lille cedex
State/Province
NORD Pas-de-calais
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Hospitalier de Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Hôpital Hôtel-Dieu
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie
City
Poitiers Cedex
ZIP/Postal Code
86000
Country
France
Facility Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
State/Province
Baden-wuerttemberg
ZIP/Postal Code
78052
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Söling Und Siehl
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34119
Country
Germany
Facility Name
Debreceni Egyetem Orvos-és Egészségtudományi Centrum
City
Debrecen
State/Province
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház
City
Szombathely
State/Province
VAS
ZIP/Postal Code
9700
Country
Hungary
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
Hadassah Medical Organization, Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
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
61100
Country
Italy
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Nagoya City University Hospital
City
Nagoya City
State/Province
Aichi
ZIP/Postal Code
467-8681
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Minami Ku
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-city
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Tokai University Hospital
City
Isehara-shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Chuo-ku
State/Province
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
9808574
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-city
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
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
138-876
Country
Korea, Republic of
Facility Name
Malopolskie Centrum Medyczne S.C.
City
Kraków
ZIP/Postal Code
30-510
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
Centrum Onkologii i Hipertermii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Geral de Santo António do Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
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
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
410 028
Country
Russian Federation
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Gleneagles Medical Centre
City
Singapore
ZIP/Postal Code
258500
Country
Singapore
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
Skånes Universitetssjukhus, Malmö
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Chang Gung Memorial Hospital (CGMH)
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Barts and The London NHS Trust
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Sunderland Royal Infirmary
City
Sunderland
ZIP/Postal Code
SR4 7TP
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 Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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