Skip to main content Skip to accessibility tools

FOUNDATION UK: A retrospective observational study of outcomes for contemporary therapy in relapsed Follicular Lymphoma

Study ID: 54756
Short Title: A retrospective study of outcomes in relapsed Follicular Lymphoma v1.0
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Haematology
Phase: N/A
Expected End Date: 31/03/2025
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

1. Age ≥18 years at initial diagnosis 2. FL lymphoma grade 1-3a at initial diagnosis 3. First systemic treatment started between Jan 2003-Dec 2018 using a contemporary therapy (anti-CD20 monoclonal antibody in combination with chemotherapy (CVP, CHOP, Bendamustine). Patients treated with initial rituximab monotherapy or radiotherapy are eligible, but this does not count as a line of therapy, as long as these patients subsequently started treatment with an anti-CD20 monoclonal antibody in combination with chemotherapy (CVP, CHOP, bendamustine) between Jan 2003 and Dec 2018. 4. At least 3 cycles of first line systemic therapy delivered. 5. Patient received the majority of their FL treatment at the participating centre (for data quality) . If not, the investigator must be able to collect complete/near complete consecutive treatment data for the full patient course. 6. Patients with r/r FL or high grade transformation: a. Relapsed or refractory FL (r/r FL) or high grade transformation (HGT) occurring at any time after initiating first line FL therapy as described above. Wherever possible, the diagnosis should be histologically confirmed. b. Patients treated for HGT who subsequently relapse with histologically confirmed FL are eligible for ongoing collection of treatment details for r/r FL. 7. Patients without FL relapse or high grade transformation: a. FL patients treated with one line of therapy as above with no subsequent relapse of FL or high grade transformation. Minimal data will be collected for these patients including treatment details and date of last follow-up or death

1. High grade transformation (HGT) concurrent with initial diagnosis of FL, or occurring prior to commencing any therapy for FL, or occurring within the first 2 cycles of first line systemic therapy 2. CNS involvement at any time 3. First line systemic treatment for FL using any regimen not listed above. Patients enrolled on a clinical trial are eligible if treated with an anti-CD20 monoclonal antibody in combination with bendamustine, CHOP or CVP 4. A significant proportion of FL treatment data is unavailable for collection .

Follicular lymphoma is a common mature B cell malignancy with a UK incidence of 3.3/100,000 people per year1. Most patients have advanced stage disease that follows a protracted and incurable disease course leading to a high overall disease prevalence. Despite advances in front line management, treatment of relapsed and refractory (r/r) FL has not been standardised and data on treatment patterns and clinical outcomes are lacking, presenting significant challenges for therapy selection and novel drug development to optimise clinical outcomes. FOUNDATION UK is a NCRI-led, multi-centre, non-interventional, retrospective, observational study aimed at collecting clinical outcome data for patients with r/r FL receiving real world contemporary therapies at participating NHS hospitals. The study will collect pseudonymised data for patients with r/r FL following initial diagnosis and treatment for FL between January 2003-December 2018, and will report on current treatment patterns and clinical outcomes by treatment line, regimen and sequence. Results of this unique study will inform clinical treatment decisions, FL management guidelines, prospective trial design, and regulatory approval of novel FL drugs. The study will be conducted at NHS sites in the UK that routinely treat patients with FL. The study will last for two years.

Study MapList of studies

Your Feedback

Return to header