Evidence map›Paper›PMID 38528445›Full record

ArticleBMC cancer2024

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.

Graham McIlroy, Siân Lax, Charlotte Gaskell, Aimee Jackson, Malcolm Rhodes, Tania Seale, Sonia Fox, Lousie Hopkins, Jessica Okosun, Sally F Barrington and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05848765 (Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05848765 phase2recruitingnot on this map

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy (REFRACT): A Randomised Phase II Trial of Investigator Choice Standard Therapy Versus Sequential Novel Therapy Experimental Arms

TypeinterventionalSponsorUniversity of BirminghamRan2023 to 2031Enrolled284ConditionsRelapsed Follicular Lymphoma, Refractory Follicular LymphomaArmsEpcoritamab, Lenalidomide, Rituximab, Obinutuzumab, Bendamustine
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. A Comprehensive Meta-Analysis of the Cardiovascular Adverse Effects of Bispecific Antibody Therapy in Hematologic Malignancies.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Graham McIlroyCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK. g.w.mcilroy.1@bham.ac.uk.
Siân LaxCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
Charlotte GaskellCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
Aimee JacksonCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
Malcolm RhodesNational Cancer Research Institute, London, UK.
Tania SealeDivision of Cancer Sciences, University of Manchester, Manchester, UK.
Sonia FoxCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
Lousie HopkinsCancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, UK.
Jessica OkosunBarts Cancer Institute, Queen Mary University of London, London, UK.
Sally F BarringtonKing's College London and Guy's and St Thomas' PET Centre, School of Biomedical Engineering and Imaging Sciences, King's College London, King's Health Partners, London, UK.
Ingo RingshausenUCL Cancer Institute, University College London, London, UK.
Alan G RamsaySchool of Cancer and Pharmaceutical Sciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.
Maria CalaminiciDepartment of Cellular Pathology Barts Health and Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.
Kim LintonDivision of Cancer Sciences, University of Manchester, Manchester, UK.
Mark BishtonTranslational Medical Sciences, University of Nottingham, Nottingham, UK.
Cancer Research UK Clinical Trials Unit · GBQueen Mary University of London · GBUniversity of Birmingham · GBUniversity of Manchester · GBCRUK Lung Cancer Centre of Excellence · GBKing's College London · GBKings Health Partners · GBNational Cancer Research Institute · GBNottingham University Hospitals NHS Trust · GB

Funding

Wellcome Trust
6 · The paper itself

Abstract

backgroundRelapsed 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.

methodsThe 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 registrationClinicalTrials.gov: NCT05848765; 08-May-2023. EUDRACT: 2022-000677-75; 10-Feb-2022.

Indexed as

Lymphoma, FollicularAdaptive Clinical Trials as TopicArmBayes TheoremClinical Trials, Phase II as TopicHumansMulticenter Studies as TopicPositron Emission Tomography Computed TomographyQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeAdaptive designBayesian power prior methodologyClinical trialEpcoritamabLenalidomideRelapsed follicular lymphoma

Identifiers

PMID38528445
PMCPMC10962099
OpenAlexW4393151986

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.