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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/NCT02947347




Registration number
NCT02947347
Ethics application status
Date submitted
26/10/2016
Date registered
27/10/2016
Date last updated
3/05/2023

Titles & IDs
Public title
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
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)
Secondary ID [1] 0 0
2016-003202-14
Secondary ID [2] 0 0
PCYC-1141-CA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Progression-Free Survival (PFS)
Timepoint [1] 0 0
2-5 years
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
2-5 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
2-5 years
Secondary outcome [3] 0 0
Infusion-Related Reaction Rate
Timepoint [3] 0 0
2-5 years
Secondary outcome [4] 0 0
Duration of Response (DOR) as Assessed by Investigator
Timepoint [4] 0 0
2-5 years
Secondary outcome [5] 0 0
Number of Participants with Adverse Events (AE)
Timepoint [5] 0 0
2-5 years

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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Transformed lymphoma

- Prior treatment for follicular lymphoma.

- Central nervous system lymphoma or leptomeningeal disease.

- Currently active, clinically significant cardiovascular disease.

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 administering 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/06/2026
Actual
Sample size
Target
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
ACT,QLD,TAS,VIC
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Mater Misericordiae Health Services - South Brisbane
Recruitment hospital [3] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 0 0
Monash Medical Centre Clayton Campus - Clayton
Recruitment hospital [5] 0 0
Andrew Love Cancer Center - Geelong
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- South Brisbane
Recruitment postcode(s) [3] 0 0
- Hobart
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Geelong
Recruitment outside Australia
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United States of America
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Alabama
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California
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Delaware
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Florida
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Illinois
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Kentucky
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Missouri
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Nebraska
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Oregon
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South Carolina
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Texas
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Virginia
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Washington
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West Virginia
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Austria
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Tirol
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Austria
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Salzburg
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Belgium
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Brussels
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Gyor
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Pecs
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Valladolid
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Kaohsiung
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Liuying
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Taipei
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Ankara
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Bornova
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Samsun
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Tekirdag
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United Kingdom
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Cornwall
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Norfolk
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Cambridge
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Leeds
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London
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Plymouth
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United Kingdom
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Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmacyclics LLC.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02947347
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/ct2/show/NCT02947347