Back to resultsA Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Idelalisib
Rituximab
Placebo to match idelalisib
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, CAL-101, GS 1101, PI3K, GS-US-312-0117, idelalisib
Eligibility Criteria
Inclusion:
- Adult subjects 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
- Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
Sites / Locations
- Clearview Cancer Institute
- Arizona Oncology Associates
- University of California, San Diego- Moores Cancer Center
- Ventura County Hematology Oncology Specialists
- UCLA
- Stanford Cancer Center
- Rocky Mountain Blood and Marrow Transplant Program
- Rocky Mountain Cancer Center
- Georgetown University Medical Center Lombardi Cancer Center
- Collaborative Medical Research Corporation
- Collaborative Research Group LLC
- Florida Cancer Specialists
- University of Florida
- Florida Cancer Specialists
- Winship Cancer Institute at Emory University
- Northwestern University
- Hackensack University Medical Center
- Hematology Oncology Associates of Northern New Jersey
- Long Island Jewish Medical Center
- Weill Cornell Medical College
- Columbia University Medical Center
- Memorial Sloan Kettering Cancer Center
- Willamette Valley Cancer Center
- Northwest Cancer Specialists, PC
- Cancer Centers of the Carolinas
- Sarah Cannon Cancer Center
- Texas Oncology, P.A.
- M.D. Anderson Cancer Center
- Cancer Care Network of South Texas
- Virginia Cancer Specialists, PC
- Oncology and Hematology Associates of Southwest Virginia, Inc
- Seattle Cancer Care Alliance
- Yakima Valley Memorial Hospital / North Star Lodge
- Medical College of Wisconsin
- Hôpital Henri Mondor
- Centre Hospitalier Régional Universitaire de Lille (CHRU)
- Hôpital Emile Muller
- Centre Hospitalier Lyon Sud
- Hôpital Pontchaillou
- Centre Henri Becquerel
- Hopital Purpan
- Gemeinschaftspraxis Hämatologie-Onkologie
- Internistische Gemeinschaftspraxis
- Universitätsklinikum Köln
- Stauferklinikum Schwäb. Gmünd
- Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
- Universitätsklinikum Ulm
- Ospedale Oncologico Regionale A. Businco
- Ospedale San Raffaele S.r.l.
- Azienda Ospedaliera Città della Salute e della Scienza di Torino
- Royal Bournemouth Hospital
- Addenbrooke's Hospital
- University Hospital of Wales
- Castle Hill Hospital
- Dorset County Hospital
- Western General Hospital
- Northwick Park Hospital
- St James's University Hospital
- Royal Liverpool University Hospital
- King's College Hospital
- Hammersmith Hospital
- Sarah Cannon Research Institute UK
- Freeman Hospital
- Princess Royal University Hospital
- Salisbury District Hospital
- Southampton General Hospital
- Royal Marsden Hospital
- Great Western Hospital
- Torbay District General Hospital
- Royal Cornwall Hospital
- New Cross Hospital
- Yeovil District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Idelalisib + rituximab
Placebo + rituximab
Arm Description
Participants will receive idelalisib plus rituximab
Participants will receive placebo to match idelalisib plus rituximab
Outcomes
Primary Outcome Measures
Progression-Free Survival
Progression-free survival 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.
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.
Lymph Node Response Rate
Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.
Overall Survival
Overall survival was defined as the interval from randomization to death from any cause.
Complete Response Rate
Complete response rate was defined as the percentage of participants who achieved a complete response.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01539512
Brief Title
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
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 Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
CLL, CAL-101, GS 1101, PI3K, GS-US-312-0117, idelalisib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Idelalisib + rituximab
Arm Type
Active Comparator
Arm Description
Participants will receive idelalisib plus rituximab
Arm Title
Placebo + rituximab
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to match idelalisib plus rituximab
Intervention Type
Drug
Intervention Name(s)
Idelalisib
Other Intervention Name(s)
Zydelig®, GS-1101, CAL 101
Intervention Description
Idelalisib 150 mg tablet administered orally twice daily
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan®
Intervention Description
Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
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
Description
Progression-free survival 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.
Time Frame
Up to 17 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.
Time Frame
Up to 17 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 SPD of index lymph nodes.
Time Frame
Up to 17 months
Title
Overall Survival
Description
Overall survival was defined as the interval from randomization to death from any cause.
Time Frame
Up to 17 months
Title
Complete Response Rate
Description
Complete response rate was defined as the percentage of participants who achieved a complete response.
Time Frame
Up to 17 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion:
Adult subjects 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
Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Jahn, MD
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
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of California, San Diego- Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Ventura County Hematology Oncology Specialists
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
UCLA
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Blood and Marrow Transplant Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Georgetown University Medical Center Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Collaborative Medical Research Corporation
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Collaborative Research Group LLC
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
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
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
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
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Weill Cornell Medical College
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
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Willamette Valley Cancer Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
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
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Network of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Yakima Valley Memorial Hospital / North Star Lodge
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hôpital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille (CHRU)
City
Lille
ZIP/Postal Code
59045
Country
France
Facility Name
Hôpital Emile Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35019
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gemeinschaftspraxis Hämatologie-Onkologie
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Stauferklinikum Schwäb. Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth
City
Neunkirchen
ZIP/Postal Code
66538
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Ospedale Oncologico Regionale A. Businco
City
Cagliari
ZIP/Postal Code
9121
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l.
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliera Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
ZIP/Postal Code
HU10 6ED
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Northwick Park Hospital
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
St James's 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
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
Sarah Cannon Research Institute UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Princess Royal University Hospital
City
Orpington
ZIP/Postal Code
BR6 8ND
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Torbay District General Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
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
Facility Name
Yeovil District Hospital
City
Yeovil
ZIP/Postal Code
BA21 4AT
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
33297794
Citation
Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.
Results Reference
derived
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.
Results Reference
derived
PubMed Identifier
24450857
Citation
Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.
Results Reference
derived
Learn more about this trial
A Randomized, Double-Blind, Placebo-Controlled Study of Idelalisib in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)
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