Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue Cancer
Conditions
Interventions
PETREA Plus will enrol all newly diagnosed follicular lymphoma patients receiving any first treatment as part of their normal care. This is an observational study which will collect data during the cl
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. > = 18 years of age at the time of consent 2. Grade 1, 2, 3A or 3B FL, or FL with histologically confirmed/clinically suspected high-grade transformation at initial presentation (de novo transformed FL) 3. Diagnostic biopsy performed within the last 6 months prior to study consent 4. Any first-line treatment planned (radiotherapy, immunotherapy, immunochemotherapy) or patients planned for initial watch and wait (these patients will have baseline data collection initially and further data will be collected if treatment (including rituximab monotherapy) starts within the study period. For patients that have already started watch and wait or treatment they can be enrolled for retrospective data collection as long as they have only received 1-2 cycles of treatment or are within one month of initiating watch and wait/treatment). 5. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients enrolled on the PETReA trial. Patients enrolled on another IMP/intervention trial may be included in PETReA Plus as long as they adhere to the inclusion/exclusion of the trial they are enrolled on. 2. Any prior treatment for follicular lymphoma or transformed follicular lymphoma (except steroids) 3. Pregnant or lactating females 4. Any serious medical condition or other reason that would prevent the subject from participating in the study in the opinion of the treating physician or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, measured using data collected from the patients’ medical records, will be assessed from patient consent before the start of first-line active treatment to follow-up every 6 months until death or study end (patients who do not die will be censored at the date they were last known alive) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anatomical response will be measured using CT scan-reported results collected from patient medical records, post-treatment. 2. Metabolic response will be measured using PET CT scan reported results (if performed) collected from patient's medical records, post-treatment. 3. Duration of response for each treatment received will be measured using data collected from patient medical records, from the start of active treatment to follow-up every 6 months until documentation of relapse, progression, high-grade transformation, start date of next line therapy, death or study end (patients who do not die will be censored at the date they were last known alive). 4. Progression-free survival will be measured using data collected from patient medical records, from patient consent prior to start of second-line active treatment to follow-up every 6 months until death or study end (patients who do not die will be censored at the date they were last known alive). 5. Time to next treatment will be measured using data collected from patient medical records, from day 1 of the last cycle of systemic induction therapy (or maintenance therapy if given), or last dose of radiotherapy to next treatment or death (patients who do not die will be censored at the date they were last known alive). 6. Time to next chemotherapy will be measured using data collected from patient medical records, from day 1 of the last cycle of systemic induction therapy (or maintenance therapy if given), or last dose of radiotherapy to next treatment or death (patients who do not die will be censored at the date they were last known alive). 7. Overall survival will be measured using data collected from patient medical records, from the date of diagnosis to the date of death from any cause (patients who do not die will be censored at the date they were last known alive). 8. First-line induction treatment will be measured using data collected from patient medical records at the start of active treatment. 9 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactPETReA Plus Trial Manager
Outcome results
None listed