drugset / Trial / NCT05848765
Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy
RandomizedSequentialOpen-labelTreatment
Summary
The aim of the REFRACT clinical trial is to find new therapies with improved outcomes compared to the current standard treatment available, in patients with relapsed or refractory follicular lymphoma. This will be done by comparing patients who have received a new treatment against patients who receive standard treatment based on their response to the treatment received.
Timeline
- Start
- 2023-09-04
- Primary completion
- 2029-05-31
- Completion
- 2031-11-30
Publications
- Gaskell C, Linton K, Bishton M, McIlroy G, Lax S, Fox S, Hopkins L, Collings R, Rhodes M, Seale T, Jackson A. The REFRACT trial: implementation of Bayesian power priors in a randomised, sequential phase II adaptive platform trial. BMC Med Res Methodol. 2025 May 3;25(1):121. doi: 10.1186/s12874-025-02575-5.
- McIlroy G, Lax S, Gaskell C, Jackson A, Rhodes M, Seale T, Fox S, Hopkins L, Okosun J, Barrington SF, Ringshausen I, Ramsay AG, Calaminici M, Linton K, Bishton M. 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. BMC Cancer. 2024 Mar 25;24(1):370. doi: 10.1186/s12885-024-12112-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Subject | Epcoritamab | Monoclonal antibody | — | Subcutaneous |
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Comparator | Obinutuzumab | Monoclonal antibody | — | — |
| Comparator | Prednisone | Other / unclassified | — | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |
| Comparator | Vincristine | Small molecule | — | — |