NCT05848765

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the REFRACT trial patients with relapsed or refractory follicular lymphoma (rrFL) will be randomised (randomly allocated) to receive a new treatment (experimental treatment) or standard treatment which will be chosen by their doctor prior to entering the trial (called investigator choice standard therapy (ICT)). There are 3 treatment rounds which will happen one after another, testing 3 different experimental treatments. The experimental treatment in each round will be compared to ICT. ICT will be a choice of 1 of 5 standard treatment options including RCHOP, RCVP, lenalidomide and rituximab, bendamustine and rituximab or obinutuzumab and bendamustine. Patients in Round 1 (R1) will be randomised using a 1:1 allocation ratio (meaning patients have a 50/50 chance of receiving the experimental treatment). In Round 1 the experimental treatment is epcoritamab combined with lenalidomide. Patients randomised to epcoritamab and lenalidomide will receive up to 12 28-day cycles of therapy; epcoritamab will be delivered as a subcutaneous injection weekly for cycles 1 and 2 and on day 1 of cycles 3-12. Lenalidomide will be taken orally on days 1-21 of each cycle. Patients in Rounds 2 (R2) and 3 (R3) (experimental treatments yet to be determined) will be randomised using a 1:4 allocation ratio in favour of the experimental treatment (meaning patients are more likely to receive the experimental treatment). The study will recruit 284 patients with rrFL over 5 years. The aim is to identify new therapies which have better outcomes compared to ICT based on patients response to treatment (tested by PET scan) after 24 weeks of therapy. Following treatment patients will be followed up yearly until the end of the trial (up to 10 years).

Conditions

• Relapsed Follicular Lymphoma
• Refractory Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Epcoritamab	Bispecific antibody
DRUG	Lenalidomide	Immunomodulatory agent
DRUG	Rituximab	Monoclonal antibody
DRUG	Obinutuzumab	Monoclonal antibody
DRUG	Bendamustine	Alkylating agent (chemotherapy drug)
DRUG	Vincristine	Antineoplastic, Vinca Alkaloid
DRUG	Doxorubicin	Anthracycline
DRUG	Cyclophosphamide	Alkylating agent (chemotherapy drug)
DRUG	Prednisone	Corticosteroid
DRUG	Investigation agent 2	The drug used in round 2 is yet to be confirmed, round 2 is estimated to open in Q4 2025 and the record will be updated when the drug has been confirmed
DRUG	Investigation agent 3	The drug used in round 3 is yet to be confirmed, round 3 is estimated to open in Q3 2027 and the record will be updated when the drug has been confirmed

Timeline

• Start date: 2023-09-04
• Primary completion: 2029-05-31
• Completion: 2031-11-30
• First posted: 2023-05-08
• Last updated: 2023-11-29

Locations

25 sites across 1 country: United Kingdom