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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
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Delaware
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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Oregon
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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United States of America
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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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Belgium
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Antwerpen
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Belgium
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Bruges
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Gent
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Liège
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Belgium
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Sint-Niklaas
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Belgium
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Wilrijk
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New Brunswick
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Quebec
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Czechia
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Hradec Kralove
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Ostrava
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Praha 5
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Praha
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Vienne
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Pessac
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Attiki
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Greece
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Larissa
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Hungary
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Somogy
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Budapest
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Debrecen
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Gyor
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Pecs
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Israel
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Ashkelon
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Israel
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Haifa
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Israel
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Petah Tikva
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Tel Aviv
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Israel
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Zerifin
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Italy
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Emilia-Romagna
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Liguria
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Piemonte
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Krakow
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Portugal
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Matosinhos
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Portugal
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Porto
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Saint Petersburg
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Spain
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Asturias
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Sevilla
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Barcelona
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Valencia
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Spain
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Valladolid
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Taiwan
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Kaohsiung City
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Taiwan
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Kaohsiung
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Taiwan
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Liuying
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Taiwan
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Taipei
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Turkey
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Ankara
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Bornova
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Gaziantep
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Kayseri
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Kocaeli
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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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United Kingdom
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Norfolk
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United Kingdom
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Cambridge
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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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
Trial website
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

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