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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
Titles & IDs
Public title
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
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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
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Secondary ID [1]
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2013-003313-17
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Secondary ID [2]
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GS-US-312-0123
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival
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Assessment method [1]
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Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).
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Timepoint [1]
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Up to 22 months
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Secondary outcome [1]
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Overall Response Rate
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Assessment method [1]
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Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.
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Timepoint [1]
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Up to 22 months
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Secondary outcome [2]
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Nodal Response Rate
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Assessment method [2]
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Nodal 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 of index lesions. Nodal response rate was to be assessed by an IRC.
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Timepoint [2]
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Up to 22 months
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Secondary outcome [3]
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Complete Response Rate
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Assessment method [3]
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Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.
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Timepoint [3]
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Up to 22 months
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.
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Timepoint [4]
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Up to 22 months
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Secondary outcome [5]
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Minimal Residual Disease Negativity Rate at Week 36
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Assessment method [5]
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Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD \< 10\^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.
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Timepoint [5]
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Up to 22 months
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
16/06/2016
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Sample size
Target
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Accrual to date
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Final
311
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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St Vincent's Hospital, Sydney - Darlinghurst
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Jarrett Street Specialist Centre - North Gosford
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Calvary Mater Newcastle - Waratah
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Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre, Department of Haematology, Level 6 - Bedford Park
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Ashford Cancer Centre Research - Kurralta Park
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Queen Elizabeth Hospital - Woodville South
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Frankston Hospital - Frankston
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Barwon Health, University Hospital Geelong - Geelong
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2010 - Darlinghurst
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2250 - North Gosford
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2298 - Waratah
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5000 - Adelaide
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5042 - Bedford Park
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5037 - Kurralta Park
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5011 - Woodville South
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Recruitment postcode(s) [8]
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3199 - Frankston
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Recruitment postcode(s) [9]
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3220 - Geelong
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Recruitment outside Australia
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Ethics approval
Ethics application status
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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).
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Trial website
https://clinicaltrials.gov/study/NCT01980888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://www.gilead.com/research/disclosure-and-transparency
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01980888