RecruitingACTRN12624000669594

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.


Sponsor

Peter MacCallum Cancer Centre

Enrollment

500 participants

Start Date

Feb 26, 2025

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Follicular lymphoma is a slow-growing type of blood cancer. When caught at early stages (stage I or II), it can often be treated with curative intent using radiotherapy. Adding immunotherapy (a drug that helps the immune system target cancer cells, such as rituximab) to radiotherapy may improve outcomes, but the evidence comparing the two approaches is not yet strong. This international registry study, led by Peter MacCallum Cancer Centre, will collect real-world data on patients with stage I–II follicular lymphoma who were treated with radiotherapy alone or with radiotherapy plus immunotherapy. By pooling data from many centres, researchers can compare progression-free survival and inform future treatment decisions. You may be eligible if you are 18 or older with a confirmed diagnosis of WHO grade 1, 2, or 3a follicular lymphoma who received curative radiotherapy. This is a retrospective and prospective registry — meaning existing medical records are reviewed and new patients can be enrolled going forward. There is no additional treatment involved; only clinical data is collected.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12624000669594