Activities per year
Abstract
Background: Relapsed or refractory follicular lymphoma (rrFL) is an incurable disease associated with shorter remissions and survival after each line of standard therapy. Many promising novel, chemotherapy-free therapies are in development, but few are licensed as their role in current treatment pathways is poorly defined. Methods: The REFRACT trial is an investigator-initiated, UK National Cancer Research Institute, open-label, multi-centre, randomised phase II platform trial aimed at accelerating clinical development of novel therapies by addressing evidence gaps. The first of the three sequential novel therapy arms is epcoritamab plus lenalidomide, to be compared with investigator choice standard therapy (ICT). Patients aged 18 years or older with biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma and assessable disease by PET-CT are eligible. The primary outcome is complete metabolic response by PET-CT at 24 weeks using the Deauville 5-point scale and Lugano 2014 criteria. Secondary outcomes include overall metabolic response, progression-free survival, overall survival, duration of response, and quality of life assessed by EQ-5D-5 L and FACT-Lym. The trial employs an innovative Bayesian design with a target sample size of 284 patients: 95 in the ICT arm and 189 in the novel therapy arms. Discussion: Whilst there are many promising novel drugs in early clinical development for rrFL, understanding the relative efficacy and safety of these agents, and their place in modern treatment pathways, is limited by a lack of randomised trials and dearth of published outcomes for standard regimens to act as historic controls. Therefore, the aim of REFRACT is to provide an efficient platform to evaluate novel agents against standard therapies for rrFL. The adaptive Bayesian power prior methodology design will minimise patient numbers and accelerate trial delivery. Trial registration: ClinicalTrials.gov: NCT05848765; 08-May-2023. EudraCT: 2022-000677-75; 10-Feb-2022.
Original language | English |
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Article number | 370 |
Journal | BMC Cancer |
Volume | 24 |
Issue number | 1 |
DOIs | |
Publication status | Published - 25 Mar 2024 |
Keywords
- Adaptive design
- Bayesian power prior methodology
- Clinical trial
- Epcoritamab
- Lenalidomide
- Relapsed follicular lymphoma
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Dive into the research topics of 'Investigator choice of standard therapy versus sequential novel therapy arms in the treatment of relapsed follicular lymphoma (REFRACT): study protocol for a multi-centre, open-label, randomised, phase II platform trial'. Together they form a unique fingerprint.Activities
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Co-chief investigator REFRACT: Relapsed Follicular lymphoma Randomised trial Against standard ChemoTherapy: A randomised phase II trial of investigator choice standard salvage immunochemotherapy versus sequential novel therapy experimental arms CRUK/22/007
Linton, K. (Other)
1 May 2022 → 31 Jul 2032Activity: Internal positions, career professional development, other peer review and other › Other › Research
Press/Media
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BSH 2023 | REFRACT: standard chemoimmunotherapy versus novel agents in R/R follicular lymphoma
Linton, K.
24/04/23
1 Media contribution
Press/Media: Research