Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000669594p
Ethics application status
Not yet submitted
Date submitted
29/04/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the use of Early-Stage Follicular Lymphoma International ImmunoTherapy Registry and initial analysis plan to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy.
Scientific title
Evaluate the use of Early-Stage Follicular Lymphoma International ImmunoTherapy Registry and initial analysis plan to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy.
Secondary ID [1] 312035 0
None
Universal Trial Number (UTN)
Trial acronym
ES FLIT Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage I-II low grade follicular lymphoma
333641 0
Condition category
Condition code
Cancer 330327 330327 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective multicentre registry-based study on patients with stage I-II follicular lymphoma (FL), designed to compare outcomes for patients treated with either radiotherapy (RT) alone or RT plus adjuvant systemic therapy that contains immunotherapy (primarily anti-CD20 therapy). This is to observe the effects of combined RT and immunotherapy for progression free survival for a minimum follow up of 3 months, from date of commencement of treatment to therefore characterise in a substantial cohort. This will be a retrospective analysis of previously collected data, therefore all relevant study assessments, including follow up status will have been completed before patient data are submitted and analysed. Information such as demographics, staging procedures (CT, PET imaging, bone marrow) disease characteristics and radiation treatment delivered, will be collected by review of medical records.
Intervention code [1] 328482 0
Not applicable
Comparator / control treatment
Non-PET staged ESFL patients treated with RT + immunotherapy
Control group
Active

Outcomes
Primary outcome [1] 338083 0
Report progression free survival for patients with early-stage follicular lymphoma (ESFL) treated with RT and immunotherapy vs RT alone.
Timepoint [1] 338083 0
Survival analysis as per institutional practice's follow up duration, for a minimum of 3 months
Secondary outcome [1] 434435 0
The interval from the date of commencement of 1st line treatment to last follow up as per institutional practice, this may be a minimum of 3 months.
Timepoint [1] 434435 0
The interval from the date of commencement of 1st line treatment to last follow up as per institutional practice, this may be up to a maximum of 5 years

Eligibility
Key inclusion criteria
1. Male or female, > 18 years of age.
2. Patients with histologically WHO grade 1, 2 or 3a FL.
3. Treated with curative intent RT to any dose
4. Intended to receive either no further treatment or adjuvant treatment containing anti-CD20 antibody therapy or other immunotherapy
5. Minimum follow up of 3 months from commencement of treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous treatment for FL
2. Composite lymphoma
3. Previous diagnosis of lymphoma
4. Treated with wide-field RT (RT involving both sides of the diaphragm targeting uninvolved nodal sites)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316385 0
Self funded/Unfunded
Name [1] 316385 0
Country [1] 316385 0
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 318642 0
None
Name [1] 318642 0
Address [1] 318642 0
Country [1] 318642 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315191 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 315191 0
https://www.petermac.org/research/doing-research-us/ethics-governance
Ethics committee country [1] 315191 0
Australia
Date submitted for ethics approval [1] 315191 0
31/05/2024
Approval date [1] 315191 0
Ethics approval number [1] 315191 0

Summary
Brief summary
The primary purpose of this study is to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy.

Who is it for?
The registry will collect information on patients with stage I-II low grade follicular lymphoma treated with curative intent radiotherapy after staging, who received either no additional therapy or systemic therapy containing immunotherapy as part of planned combined modality therapy.

Study details:
Eligible patients will be identified using local patient databases, and local medical records will be reviewed. Information on demographics, staging procedures (bone marrow, CT, PET imaging), disease characteristics including WHO tumour grade (1-3b) and extranodal site, radiation treatment delivered (RT dose and method, e.g. IFRT, Involved Site RT(ISRT)), systemic therapy delivered (immunotherapy details if given and other systemic therapies if given) and follow-up information will be collected and contained within a RedCap database.

It is anticipated that in coming years, new cohorts of patients with stage I-II follicular lymphoma treated with immunotherapy will become available for inclusion and that outcomes for existing cohorts will be updated. For this reason, a registry will be established, both to enable research to be conducted on retrospectively acquired data from cohorts of patients already documented and to enable updated outcome data to be uploaded for these existing cohorts. The registry will also accommodate new patient cohorts as they become available as immunotherapy becomes more widely used. Hence the registry will ultimately include a combination of retrospective and prospective elements.

The registry's utilization can contribute to demonstrating the efficacy of systemic therapy in reducing the risk of death or progression and informing therapeutic decisions to enhance health outcomes in managing follicular lymphoma, where immunotherapy's historical underutilization in stage I-II FL has resulted in a lack of notable improvement in overall survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133942 0
Dr Michael MacManus
Address 133942 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 133942 0
Australia
Phone 133942 0
+6199288924
Fax 133942 0
Email 133942 0
michael.macmanus@petermac.org
Contact person for public queries
Name 133943 0
Michael MacManus
Address 133943 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 133943 0
Australia
Phone 133943 0
+6199288924
Fax 133943 0
Email 133943 0
michael.macmanus@petermac.org
Contact person for scientific queries
Name 133944 0
Michael MacManus
Address 133944 0
Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne Victoria 3000
Country 133944 0
Australia
Phone 133944 0
+6199288924
Fax 133944 0
Email 133944 0
michael.macmanus@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.