Back to resultsEfficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Idelalisib
Ofatumumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Chronic Lymphocytic Leukemia, GS-1101, CAL-101, Ofatumumab
Eligibility Criteria
Key Inclusion Criteria:
- Adults with previously treated recurrent CLL who have measurable lymphadenopathy
- Require therapy for CLL
- Have experienced CLL progression < 24 months since the completion of the last prior therapy
- Have disease that is not refractory to ofatumumab
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- City of Hope
- California Cancer Associates for Research and Excellence (CCARE)
- Kaiser Permanente
- Coastal Integrative Cancer Care
- Stanford University Medical Center
- Kaiser Permanente Vallejo Medical Center
- Kaiser Permanente of Colorado
- Saint Mary's Regional Cancer Center
- Cancer Specialists of North Florida
- Georgia Regents University
- Montgomery Cancer Center
- Center for Cancer and Blood Disorders, PC
- Dana Farber Cancer Institute
- Washington University Medical Center
- Comprehensive Cancer Centers of Nevada
- Weill Cornell Medical Center
- Oncology Hematology Care, Inc.
- The Ohio State University Medical Center
- Oregon Health and Science University
- Upstate Oncology Associates
- Tennessee Oncology, PLLC
- Tenessee Oncology, PLLC
- Utah Cancer Specialists
- Northwest Medical Specialties
- Saint George and Sutherland Hospitals
- Prince of Wales Hospital
- Westmead Hospital
- Royal Brisbane and Women's Hospital
- Haematology and Oncology Clinics of Australia at Mater
- Ashford Cancer Centre Research
- Box Hill Hospital
- Frankston Hospital
- Queen Elizabeth Hospital
- Ziekenhuis Netwerk Antwerpen
- Cliniques Universitaires Saint Luc
- Universitair Ziekenhuis Gent
- Universitaire Ziekenhuis Gasthuisberg
- Tom Baker Cancer Centre
- Cross Cancer Institute
- Cancer Care Manitoba
- Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
- Centre Hospitalier Universitaire de Montréal
- Centre Hospitalier Regional de Rimouski
- Saskatchewan Cancer Agency
- Cancer Care Manitoba
- Aalborg Hospital
- Aarhus University Hospital
- Center Hospitalier Universitaire de Bordeaux
- Hôpital Saint Louis
- Centre Hospitalier de Perpignan
- Centre Hospitalier Universitaire Nancy
- Centre Hospitalier Universitaire Purpan
- CHRU Clermont- Ferrand CHU Estaing
- Centre Hospitalier Universitaire Hôpital Avicenne
- University College Cork
- Saint James's Hospital
- Collegium Medicum Uniwersytetu Jagiellonskiego w K
- Wojewódzki Szpital Specjalistyczny im. Janusza Kor
- Szpital Specjalistyczny w Brzozowie
- Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
- Centralny Szpital Kliniczny MSW
- Samodzielny Publiczny Szpital Kliniczny N1 Klinika
- Hospital Clínic i Provincial
- Hospital Vall d´Hebrón
- Hospital Universitario La Princesa
- Hospital Universitario 12 de Octubre
- Hospital Puerta de Hierro Majadahonda
- Hospital Morales Meseguer
- Sunderby Sjukhus
- Karolinska University Hospital Solna
- Karolinska University Hospital Huddinge
- Birmingham Heartlands Hospital
- Darent Valley Hospital
- Royal Surrey County Hospital NHS Trust
- Haematology and Transplant Unit
- Norfolk and Norwich University Hospital
- Saint James's University Hospital
- University College London
- University College London
- Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Idelalisib+ofatumumab
Ofatumumab
Arm Description
Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses) Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation. Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Outcomes
Primary Outcome Measures
Progression-Free Survival
Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.
Secondary Outcome Measures
Overall Response Rate
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response 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. Overall response rate was analyzed using KM estimates.
Lymph Node Response Rate
Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
Overall Survival
Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Complete Response Rate
Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01659021
Brief Title
Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Official Title
A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Study Start Date
December 4, 2012 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (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 ofatumumab 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
CLL, Chronic Lymphocytic Leukemia, GS-1101, CAL-101, Ofatumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idelalisib+ofatumumab
Arm Type
Experimental
Arm Description
Randomized Initial Therapy (24 weeks): Idelalisib + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.
Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Arm Title
Ofatumumab
Arm Type
Active Comparator
Arm Description
Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)
Continuing Therapy/Observation: Observation until the earliest of participant withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation.
Long-Term Follow-up: Participants were followed for up to 5 years. Information on medical status, anti-tumor treatments, secondary malignancies, and survival status were collected annually during a routine clinic visit or other contact, such as telephone.
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig®, GS-1101, CAL-101
Intervention Description
150 mg tablets administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
Arzerra®
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.
Time Frame
Randomization to End of Study (up to 60 months)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.
Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.
Partial response 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. Overall response rate was analyzed using KM estimates.
Time Frame
Randomization to End of Study (up to 60 months)
Title
Lymph Node Response Rate
Description
Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.
Time Frame
Randomization to End of Study (up to 60 months)
Title
Overall Survival
Description
Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.
Time Frame
Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)
Title
Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation
Description
Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.
Time Frame
Randomization to End of Study (up to 60 months)
Title
Complete Response Rate
Description
Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).
Time Frame
Randomization to End of Study (up to 60 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Adults with previously treated recurrent CLL who have measurable lymphadenopathy
Require therapy for CLL
Have experienced CLL progression < 24 months since the completion of the last prior therapy
Have disease that is not refractory to ofatumumab
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
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
California Cancer Associates for Research and Excellence (CCARE)
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Coastal Integrative Cancer Care
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Kaiser Permanente Vallejo Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Kaiser Permanente of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Saint Mary's Regional Cancer Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Cancer Specialists of North Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Montgomery Cancer Center
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Center for Cancer and Blood Disorders, PC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Upstate Oncology Associates
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tenessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1781
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Saint George and Sutherland Hospitals
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australia at Mater
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Frankston Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
Ziekenhuis Netwerk Antwerpen
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Tom Baker Cancer Centre
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
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Hopital Regional De Sudbury Regional Hospital (HRSRH) - Regional Cancer Program (RCP)
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre Hospitalier Regional de Rimouski
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Saskatchewan Cancer Agency
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 1A5
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Aalborg Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Center Hospitalier Universitaire de Bordeaux
City
Pessac Cedex
State/Province
Aquitaine
ZIP/Postal Code
33604
Country
France
Facility Name
Hôpital Saint Louis
City
Paris Cedex 10
State/Province
Ile-de-france
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
State/Province
Languedoc-Roussillon
ZIP/Postal Code
66046
Country
France
Facility Name
Centre Hospitalier Universitaire Nancy
City
Vandoeuvre
State/Province
Limousin, Lorraine
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier Universitaire Purpan
City
Toulouse Cedex
State/Province
Midi-pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU Clermont- Ferrand CHU Estaing
City
Auvergne
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Hospitalier Universitaire Hôpital Avicenne
City
Ile-de-france
ZIP/Postal Code
93009
Country
France
Facility Name
University College Cork
City
Cork
Country
Ireland
Facility Name
Saint James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Collegium Medicum Uniwersytetu Jagiellonskiego w K
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Janusza Kor
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Mikolaja Kopernika w Lodzi
City
Lódz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSW
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny N1 Klinika
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Hospital Clínic i Provincial
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d´Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Sunderby Sjukhus
City
Luleå
ZIP/Postal Code
971 80
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5ST
Country
United Kingdom
Facility Name
Darent Valley Hospital
City
Dartford
State/Province
England
ZIP/Postal Code
DA2 8DA
Country
United Kingdom
Facility Name
Royal Surrey County Hospital NHS Trust
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Haematology and Transplant Unit
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Saint James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 6BT
Country
United Kingdom
Facility Name
Department of Haematology, Cancer and Haematology Centre, Churchill Hospital (Oxford University Hospitals)
City
Oxford
ZIP/Postal Code
OX3 7LE
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
Citations:
PubMed Identifier
28257752
Citation
Jones JA, Robak T, Brown JR, Awan FT, Badoux X, Coutre S, Loscertales J, Taylor K, Vandenberghe E, Wach M, Wagner-Johnston N, Ysebaert L, Dreiling L, Dubowy R, Xing G, Flinn IW, Owen C. Efficacy and safety of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukaemia: an open-label, randomised phase 3 trial. Lancet Haematol. 2017 Mar;4(3):e114-e126. doi: 10.1016/S2352-3026(17)30019-4.
Results Reference
result
Citation
Jones J, Robak T, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 7515]. American Society of Clinical Oncology (ASCO) 52nd Annual Meeting; 2016 02 - 06 June; Chicago, IL.
Results Reference
result
Citation
Jones JA, Wach M, Robak T, Brown JR, Menter AR, Vanderberghe E, et al. Results of a Phase 3 Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (IDELA) in Combination with Ofatumumab (OFA) for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster 7023]. American Society of Clinical Oncology (ASCO) 51st Annual Meeting; 2015 29 May - 02 June; Chicago, IL.
Results Reference
result
Citation
Robak T, Jones J, Wach M, Brown JR, Menter AR, Vandenberghe E, et al. Updated results of a phase 3 randomized, controlled study of idelalisib in combination with ofatumumab for previously treated chronic lymphocytic leukemia (CLL) [Poster 213]. 21st Congress of the European Hematology Association (EHA); 2015 09-12 June; Copenhagen, Denmark.
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Citation
Robak T, Wach M, Jones J, Owen C, Brown J, Menter A, et al. Results Of A Phase 3 Randomized Controlled Study Evaluating The Efficacy And Safety Of Idelalisib (Idela) In Combination With Ofatumumab (Ofa) For Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster LB598]. 20th Congress of the European Hematology Association (EHA); 2015 11-14 June; Vienna, Austria.
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Citation
Flinn I, Kimby E, Cotter FE, Giles FJ, Janssens A, Pulczynski EJ, et al. A Phase 3, Randomized, Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia (CLL) [Poster TPS7131]. American Society of Clinical Oncology (ASCO); 2013 May 31-June 4; Chicago, IL.
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PubMed Identifier
32599655
Citation
Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.
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Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia
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