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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02947347
Registration number
NCT02947347
Ethics application status
Date submitted
26/10/2016
Date registered
27/10/2016
Date last updated
26/08/2024
Titles & IDs
Public title
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)
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Secondary ID [1]
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2016-003202-14
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Secondary ID [2]
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PCYC-1141-CA
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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:
Follicular Lymphoma
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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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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 - ibrutinib
Treatment: Drugs - placebo to match ibrutinib
Treatment: Drugs - rituximab
Experimental: (Arm A) ibrutinib + rituximab - Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance.
Placebo comparator: (Arm B) placebo + rituximab - Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.
Treatment: Drugs: ibrutinib
ibrutinib 560mg administered orally
Treatment: Drugs: placebo to match ibrutinib
placebo capsules to match ibrutinib administered orally
Treatment: Drugs: rituximab
rituximab 375mg/m\^2 IV
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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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Number of Participants with Progression-Free Survival (PFS)
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Assessment method [1]
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PFS, is assessed by the investigator, will be analyzed in the intent to treat (ITT) population, comparing the 2 treatment arms (Arm A and Arm B).
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Timepoint [1]
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2-5 years
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR of the two treatment arms will be compared using the Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by the randomization stratification factors, under the hierarchical procedure.
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Timepoint [1]
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2-5 years
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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Overall survival is defined as the interval between the date of randomization and the date of the participant's death from any cause.
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Timepoint [2]
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2-5 years
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Secondary outcome [3]
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Infusion-Related Reaction Rate
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Assessment method [3]
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Infusion-related reaction rate Arm A vs. Arm B.
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Timepoint [3]
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2-5 years
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Secondary outcome [4]
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Duration of Response (DOR) as Assessed by Investigator
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Assessment method [4]
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DOR is defined as the time from the date of the participant's documented disease progression or death due to the disease, whichever occurs first.
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Timepoint [4]
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2-5 years
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Secondary outcome [5]
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Number of Participants with Adverse Events (AE)
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Assessment method [5]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [5]
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2-5 years
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Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
* Measurable disease
* Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
* Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
* Adequate hematologic function within protocol-defined parameters.
* Adequate hepatic and renal function within protocol-defined parameters.
* ECOG performance status score of 0-2.
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Minimum age
60
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
* Transformed lymphoma
* Prior treatment for follicular lymphoma.
* Central nervous system lymphoma or leptomeningeal disease.
* Currently active, clinically significant cardiovascular disease.
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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
Active, not recruiting
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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
1/01/2017
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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
25/06/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
445
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Recruitment in Australia
Recruitment state(s)
ACT,QLD,TAS,VIC
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Mater Misericordiae Health Services - South Brisbane
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Royal Hobart Hospital - Hobart
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Monash Medical Centre Clayton Campus - Clayton
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Recruitment hospital [5]
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Andrew Love Cancer Center - Geelong
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- Garran
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- South Brisbane
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- Hobart
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- Clayton
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- Geelong
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Funding & Sponsors
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Name
Pharmacyclics LLC.
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.
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Trial website
https://clinicaltrials.gov/study/NCT02947347
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
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 not provided in
https://clinicaltrials.gov/study/NCT02947347
Download to PDF