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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01732926
Registration number
NCT01732926
Ethics application status
Date submitted
14/11/2012
Date registered
26/11/2012
Date last updated
16/11/2018
Titles & IDs
Public title
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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Scientific 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 Indolent Non-Hodgkin Lymphomas
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Secondary ID [1]
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2012-004034-42
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Secondary ID [2]
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GS-US-313-0125
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Universal Trial Number (UTN)
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Trial acronym
Bridalveil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Indolent Non-Hodgkin's Lymphomas
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0
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Idelalisib
Treatment: Drugs - Rituximab
Treatment: Drugs - Bendamustine
Treatment: Drugs - Placebo
Experimental: Rituximab + Bendamustine + Idelalisib - Participants will receive rituximab + bendamustine + idelalisib.
Experimental: Rituximab + Bendamustine + Placebo - Participants will receive rituximab + bendamustine + placebo.
Treatment: Drugs: Idelalisib
150 mg tablet administered orally twice daily
Treatment: Drugs: Rituximab
375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
Treatment: Drugs: Bendamustine
90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
Treatment: Drugs: Placebo
Tablet 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 (PFS)
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Assessment method [1]
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PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
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Timepoint [1]
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Secondary outcome [1]
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Complete Response Rate (CR)
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Assessment method [1]
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Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.
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Timepoint [1]
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Secondary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.
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Timepoint [2]
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Secondary outcome [3]
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Lymph Node Response Rate
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Assessment method [3]
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Lymph node response rate is defined as the proportion of participants who achieve = 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.
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Timepoint [3]
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Secondary outcome [4]
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Overall Survival (OS)
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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.
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Timepoint [4]
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Eligibility
Key inclusion criteria
Key
- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following
1. Follicular lymphoma (FL) Grade 1, 2, or 3a
2. Small lymphocytic lymphoma (SLL)
3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
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Minimum age
18
Years
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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
- History of lymphoid malignancy other than those allowed per inclusion criteria.
- Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic
liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic
obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- Prior treatment with bendamustine that was not effective.
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 administering 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
Terminated
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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
2/01/2013
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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
17/05/2016
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Sample size
Target
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Accrual to date
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Final
475
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Haematology and Oncology Clinics of Australia Gold Coast - South Brisbane
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Royal Adelaide Hospital - Adelaide
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Adelaide Cancer Centre - Kurralta Park
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Box Hill Hospital - Box Hill
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Monash Medical Centre - Clayton
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Saint Vincent's Hospital - Fitzroy
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Western Hospital - Footscray
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Royal Perth Hospital - Perth
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2031 - Randwick
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4101 - South Brisbane
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5000 - Adelaide
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5037 - Kurralta Park
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3128 - Box Hill
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3168 - Clayton
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3065 - Fitzroy
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3011 - Footscray
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6000 - Perth
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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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Ethics approval
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Summary
Brief summary
The primary objective of this study is to evaluate the addition of idelalisib to
bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated
indolent non-Hodgkin lymphoma (iNHL).
An increased rate of deaths and serious adverse events (SAEs) among participants with
front-line chronic lymphocytic leukemia (CLL) and early-line 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/ct2/show/NCT01732926
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01732926
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