History of Changes for Study: NCT01569295

A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL)

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Study Record Versions

Version	Submitted Date	Changes
1	March 30, 2012	None (earliest Version on record)
2	May 31, 2012	Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Oversight
3	June 18, 2012	Study Status
4	July 18, 2012	Study Status and Contacts/Locations
5	August 29, 2012	Study Status and Contacts/Locations
6	September 15, 2012	Study Status and Contacts/Locations
7	November 12, 2012	Contacts/Locations and Study Status
8	November 28, 2012	Contacts/Locations and Study Status
9	January 12, 2013	Arms and Interventions, Contacts/Locations, Study Description, Study Status, Study Identification and Conditions
10	March 11, 2013	Contacts/Locations and Study Status
11	March 18, 2013	Contacts/Locations and Study Status
12	June 24, 2013	Contacts/Locations and Study Status
13	August 20, 2013	Study Status and Contacts/Locations
14	September 20, 2013	Contacts/Locations and Study Status
15	December 23, 2013	Outcome Measures, Study Status, Study Description, Contacts/Locations, Arms and Interventions and Study Identification
16	February 6, 2014	Study Status and Contacts/Locations
17	March 7, 2014	Contacts/Locations and Study Status
18	April 14, 2014	Study Status and Contacts/Locations
19	May 22, 2014	Study Status and Contacts/Locations
20	July 2, 2014	Study Status and Contacts/Locations
21	July 24, 2014	Contacts/Locations and Study Status
22	September 5, 2014	Recruitment Status, Contacts/Locations, Arms and Interventions, Study Status, Outcome Measures and Conditions
23	October 21, 2014	Study Status and Contacts/Locations
24	May 1, 2015	Contacts/Locations and Study Status
25	December 4, 2015	Study Status
26	January 20, 2016	Study Status
27	May 24, 2016	Study Status, Study Design and Eligibility
28	June 9, 2017	Contacts/Locations, Study Status, Oversight, Eligibility and Study Identification
29	October 24, 2017	Study Status
	Results Submission Events
December 18, 2017		Returned after QC review: January 18, 2018
30	January 29, 2018	Study Status, Outcome Measures, More Information, References, Arms and Interventions, Adverse Events, Baseline Characteristics, Participant Flow, Contacts/Locations and Study Description
31	June 25, 2018	Study Status
32	October 9, 2018	Study Status
33	January 7, 2019	Study Status
34	May 6, 2019	Study Status
35	June 26, 2019	Recruitment Status, Study Status and IPDSharing
36	March 2, 2020	Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, Study Status, More Information, IPDSharing, Document Section, Eligibility, Arms and Interventions, Conditions, Study Description and Study Identification

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	GS-US-312-0115
Brief Title:	A Randomized, Double-Blind and Placebo-Controlled Study of Idelalisib in Combination With Bendamustine and 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 Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Secondary IDs:	2011-006292-20 [EudraCT Number]

Study Status


Record Verification:	September 2014
Overall Status:	Active, not recruiting
Study Start:	June 2012
Primary Completion:	December 2016 [Anticipated]
Study Completion:	December 2017 [Anticipated]

First Submitted:	March 27, 2012
First Submitted that Met QC Criteria:	March 30, 2012
First Posted:	April 3, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	September 5, 2014
Last Update Posted:	September 9, 2014 [Estimate]

Sponsor/Collaborators


Sponsor:	Gilead Sciences
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description


Brief Summary:	This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib or placebo. All subjects will be administered bendamustine and rituximab.
Detailed Description:

Conditions


Conditions:	Chronic Lymphocytic Leukemia
Keywords:	Zydelig CLL CAL 101 CAL-101 GS 1101 GS-1101 PI3K Rituxan Rituximab Bendamustine Leukemia idelalisib

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	390 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Idelalisib+bendamustine+rituximab

Participants will receive idelalisib plus bendamustine and rituximab for up to 30 months.

Drug: Idelalisib

Idelalisib 150 mg administered orally twice daily

Other Names:

GS-1101
CAL 101
CAL-101
Zydelig®

Drug: Rituximab

Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions

Other Names:

Rituxan®
MabThera

Drug: Bendamustine

Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions

Other Names:

Ribomustin
Treanda®
SDX-105

Placebo Comparator: Placebo to match idelalisib+bendamustine+rituximab

Participants will receive placebo to match idelalisib plus bendamustine and rituximab for up to 30 months.

Drug: Rituximab

Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions

Other Names:

Rituxan®
MabThera

Drug: Bendamustine

Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions

Other Names:

Ribomustin
Treanda®
SDX-105

Drug: Placebo to match idelalisib

Placebo to match idelalisib administered orally twice daily

Outcome Measures


Primary Outcome Measures:
1.	Progression-Free Survival [ Time Frame: Up to 30 months ] Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause.
Secondary Outcome Measures:
1.	Overall Response Rate [ Time Frame: Up to 30 months ] Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response.
2.	Lymph Node Response Rate [ Time Frame: Up to 30 months ] Lymph node response rate is defined as the proportion of participants who achieve a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
3.	Overall Survival [ Time Frame: Up to 30 months ] Overall survival (OS) is defined as the interval from randomization to death from any cause.
4.	Complete Response Rate [ Time Frame: Up to 30 months ] Complete response (CR) rate is defined as the proportion of participants who achieve a CR.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion: Previously treated recurrent CLL Measurable lymphadenopathy Requires therapy for CLL Has experienced CLL progression <36 months since the completion of the last prior therapy Exclusion: Recent history of a major non-CLL malignancy Evidence of an ongoing infection CLL refractory to bendamustine Concurrent participation in another therapeutic clinical trial

Contacts/Locations


Study Officials:	Thomas Jahn, MD Study Director Gilead Sciences
Locations:	United States, Alabama
	Clearview Cancer Institute Huntsville, Alabama, United States, 35805
	United States, California
	Stanford Cancer Center Palo Alto, California, United States, 94304
	UCLA Medical Center Santa Monica, California, United States, 90404
	United States, Colorado
	Rocky Mountain Cancer Center Denver, Colorado, United States, 80218
	United States, Florida
	University of Florida Gainsville, Florida, United States, 32610
	United States, Georgia
	Winship Cancer Institute at Emory University Atlanta, Georgia, United States, 30322
	United States, Massachusetts
	Dana Farber Cancer Institute Boston, Massachusetts, United States, 02215
	United States, Nebraska
	University of Nebraska Medical Center Omaha, Nebraska, United States, 68198
	United States, New Jersey
	Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
	Hematology Oncology Associates of Northern New Jersey Morristown, New Jersey, United States, 07962
	United States, New York
	Long Island Jewish Medical Center New Hyde Park, New York, United States, 11042
	Columbia University Medical Center New York, New York, United States, 10032
	Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
	United States, Oregon
	Willamette Valley Cancer Center Eugene, Oregon, United States, 97401
	Northwest Cancer Specialists, PC Portland, Oregon, United States, 97225
	United States, South Carolina
	Charleston Hematology Oncology Charleston, South Carolina, United States, 29414
	United States, Texas
	Texas Oncology Austin, Texas, United States, 78731
	Texas Oncology PA Dallas, Texas, United States, 78246
	Texas Oncology, P.A. Fort Worth, Texas, United States, 76104
	M.D. Anderson Cancer Center Houston, Texas, United States, 77030
	United States, Washington
	Seattle Cancer Care Alliance Seattle, Washington, United States, 98109
	Cancer Care Northwest, US Oncology Spokane, Washington, United States, 99202
	Yakima Valley Memorial Hospital Yakima, Washington, United States, 98902
	United States, Wisconsin
	Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
	Argentina
	Instituto de Hematologia y Medicina Clinica "Dr. Ruben Davoli" Rosario, Argentina, 2000
	Australia
	Princess Alexandra Hospital Woolloongabba, Australia, 4102
	Australia, New South Wales
	St Vincent's Hospital - Sydney Darlinghurst, New South Wales, Australia, 2010
	Gosford Hospital Gosford, New South Wales, Australia, 2250
	Australia, South Australia
	Royal Adelaide Hospital Adelaide, South Australia, Australia, 5000
	Australia, Victoria
	Monash Medical Centre - Clayton Campus Clayton, Victoria, Australia, 3168
	Australia, Western Australia
	Sir Charles Gairdner Hospital Nedlands, Western Australia, Australia, 6009
	Belgium
	Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg Antwerpen, Belgium, 2060
	UZ Gent Gent, Belgium, 9000
	UZ Leuven Leuven, Belgium, 3000
	Canada, Manitoba
	Cancer Care Manitoba Winnipeg, Manitoba, Canada, R3A 1R9
	Croatia
	Clinical Hospital "Dubrava" Zagreb, Croatia, 10000
	Klinichki Bolnicki Centar-Zagreb Zagreb, Croatia, 10000
	University Hospital Merkur Zagreb, Croatia, 10000
	Czech Republic
	Fakultni nemocnice Brno Brno, Czech Republic, 625 00
	Fakultni nemocnice Hradec Kralove Hradec Kralove, Czech Republic, 500 05
	Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52
	France
	Hôpital Henri Mondor Creteil, France, 94010
	Centre Jean Bernard - Clinique Victor Hugo Le Mans cedex, France, 72015
	CHRU Lille-Hôpital Claude Huriez Lille, France, 59045
	Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes Lyon, France, 69373
	Centre Hospitalier de Mulhouse Mulhouse, France, 68100
	CHU Hôtel-Dieu-Service Hématologie Nantes, France, 44 093
	Hopital Cochin Paris, France, 75104
	Centre Hospitalier Lyon Sud Pierre Bénite, France, Pierre Bénite
	Hopital Purpan Toulouse, France, 31059
	Hôpitaux de Brabois Vandoeuvre-lés-Nancy, France, 54511
	Greece
	G. Genimatas Hospital Athens, Greece, 11527
	University General Hospital of Patras Patras, Greece, 26500
	Hungary
	Semmelweis Egyetem Budapest, Hungary, 1083
	Országos Onkológiai Intézet Budapest, Hungary, 1122
	Debreceni Egyetem Orvos- és Egészségtudományi Centrum Debrecen, Hungary, 4032
	Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár, Hungary, 7400
	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged, Hungary, 6720
	Ireland
	Mater Misericordiae Hospital Dublin, Ireland
	Italy
	Spedali Civili di Brescia Brescia, Italy, 25123
	Ospedale Oncologico Regionale A. Businco Cagliari, Italy, 9121
	O Spedale San Rafaelle S.r.l. Milano, Italy, 20132
	Azienda Ospedaliera Niguarda Ca Granda Milano, Italy, 20162
	Policlinico Universitario "A. Gemelli" Roma, Italy, 00168
	Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino, Italy, 10126
	New Zealand
	Wellington Hospital Wellington South, New Zealand
	Poland
	Szpital Specjalistyczny w Brzozowie Brzozow, Poland, 36-200
	Malopolskie Centrum Medyczne Krakow, Poland, 30-510
	Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi Lodz, Poland, 93-510
	Samodzielny Publiczny Szpital Kliniczny Nr 1 Lublin, Poland, 20-081
	Wojewodzki Szpital w Opolu Opole, Poland, 43-372
	Centralny Szpital Kliniczny MSW w Warszawie Warszawa, Poland, 02-507
	Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Warszawa, Poland, 02-781
	Portugal
	Hospital Santa Maria Lisboa, Portugal, 1649-035
	"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE) Porto, Portugal, 4200-072
	Romania
	Emergency County Clinical Hospital Brasov Brasov, Romania, 500326
	"Fundeni" Clinical Institute Bucharest, Romania, 22328
	"Colentina" Clinical Hospital Bucharest, Romania
	Regional Oncology Institute Iasi Iasi, Romania, 700483
	Russian Federation
	Russian Oncology Research Center (N.N. Blokhin) Moscow, Russian Federation, 115478
	Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko Nizhniy Novgorod, Russian Federation, 603126
	Novosibirsk State Regional Clinical Hospital Novosibirsk, Russian Federation
	Ryazan Regional Clinical Hospital Ryazan, Russian Federation, 390039
	Saratov State Medical University Saratov, Russian Federation, 410028
	Research Institute of Hematology and Blood Transfusion St. Petersburg, Russian Federation, 193024
	Volgograd Regional Oncology Center #1 Volgograd, Russian Federation, 400138
	Spain
	Hospital Universitario de La Princesa Madrid, Spain, 28033
	Spain, Cataluña
	Hospital Universitario Germans Trias i Pujol Badalona, Cataluña, Spain, 08916
	Hospital Clinic de Barcelona Barcelona, Cataluña, Spain, 8036
	Hospital de la Santa Creu i Sant Pau Barcelona, Cataluña, Spain, 8041
	Spain, Madrid, Communidad de
	Hospital 12 de Octubre Madrid, Madrid, Communidad de, Spain, 28041
	Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Communidad de, Spain, 28222
	Turkey
	Gazi University Medical Faculty Gazi Hospital Ankara, Turkey, 06500
	Ankara University Medical Faculty Ankara, Turkey, 6590
	Istanbul University Istanbul Medical Faculty Istanbul, Turkey, 34093
	Ondokuz Mayis University Faculty of Medicine Samsun, Turkey, 55239
	United Kingdom
	Birmingham Heartlands Hospital Birmingham, United Kingdom, B9 5SS
	Kent and Canterbury Hospital Canterbury, United Kingdom, CT1 3NG
	University Hospital of Wales Cardiff, United Kingdom, CF14 4XW
	Dorset County Hospital Dorchester, United Kingdom, DT1 2JY
	St James's University Hospital Leeds, United Kingdom, LS9 7TF
	Royal Liverpool University Hospital Liverpool, United Kingdom, L7 8XP
	St Bartholomews Hospital London, United Kingdom, EC1A 7BE
	University College London London, United Kingdom, NW1 2PG
	King's College Hospital London, United Kingdom, SE5 9RS
	Hammersmith Hospital London, United Kingdom, W12 0NN
	Christie Hospital Manchester, United Kingdom, M20 4BX
	Nottingham University Hospitals NHS Trust Nottingham, United Kingdom, NG51PB
	Churchill Hospital Oxford, United Kingdom, OX3 7LE
	Royal Cornwall Hospital Truro, United Kingdom, TR1 3LJ
	New Cross Hospital Wolverhampton, United Kingdom, WV10 0QP

IPDSharing


Plan to Share IPD:

References


Links:
Available IPD/Information: