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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01980888




Registration number
NCT01980888
Ethics application status
Date submitted
5/11/2013
Date registered
11/11/2013
Date last updated
19/11/2018

Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
2013-003313-17
Secondary ID [2] 0 0
GS-US-312-0123
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Idelalisib
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Placebo

Experimental: Idelalisib+bendamustine+rituximab - Participants will receive idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.

Placebo comparator: Placebo+bendamustine+rituximab - Participants will receive placebo to match idelalisib for 96 weeks plus bendamustine+rituximab for 21 weeks.


Treatment: Drugs: Idelalisib
150 mg tablet administered orally twice daily

Treatment: Drugs: Bendamustine
Administered intravenously at a starting dose of 90 mg/m\^2 for up to 6 cycles. Dosing will be based on mg/m\^2 of body surface area.

Treatment: Drugs: Rituximab
Single-use vials administered intravenously weekly starting at 375 mg/m\^2 on Day 1 (Week 0) and 500 mg/m\^2 thereafter for a total of 6 infusions

Treatment: Drugs: Placebo
Placebo to match idelalisib administered orally twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
Up to 22 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
Up to 22 months
Secondary outcome [2] 0 0
Nodal Response Rate
Timepoint [2] 0 0
Up to 22 months
Secondary outcome [3] 0 0
Complete Response Rate
Timepoint [3] 0 0
Up to 22 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to 22 months
Secondary outcome [5] 0 0
Minimal Residual Disease Negativity Rate at Week 36
Timepoint [5] 0 0
Up to 22 months

Eligibility
Key inclusion criteria
Key

* Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
* No prior therapy for CLL other than corticosteroids for disease complications
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* History of non-infectious pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/06/2016
Sample size
Target
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Jarrett Street Specialist Centre - North Gosford
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 0 0
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Centre, Department of Haematology, Level 6 - Bedford Park
Recruitment hospital [6] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [7] 0 0
Queen Elizabeth Hospital - Woodville South
Recruitment hospital [8] 0 0
Frankston Hospital - Frankston
Recruitment hospital [9] 0 0
Barwon Health, University Hospital Geelong - Geelong
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2250 - North Gosford
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
5011 - Woodville South
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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District of Columbia
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United States of America
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Florida
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Indiana
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Iowa
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United States of America
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Maryland
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United States of America
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Nevada
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New Jersey
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New York
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Ohio
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Belgium
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Antwerpen
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Belgium
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Brugge
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Belgium
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Leuven
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Canada
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Manitoba
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Ontario
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Quebec
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Croatia
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Zagreb
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Brno
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Hradec Kralove
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Plzen
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Prague 10
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Lille
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Paris
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France
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Tours
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Hungary
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Komárom - Esztergom
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Somogy
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Budapest
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Debrecen
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Gyula
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Pecs
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Hungary
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Szeged
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Italy
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Puglia
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Italy
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Cagliari
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Italy
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Milan
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Italy
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Modena
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Italy
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Novara
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Pomorskie
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Krakow
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Lodz
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Warsaw
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Warszawa
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Wroclaw
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Romania
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Brasov
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Bucharest
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Spain
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Cataluña
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Barcelona
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Madrid
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England
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Kent
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Surrey
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Cardiff
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Liverpool
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London
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Oxford
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Southampton
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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).
Trial website
https://clinicaltrials.gov/study/NCT01980888
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01980888