Health TrialsbyHealthPanel

Relapsed Follicular Lymphoma Randomised Trial Against Standard ChemoTherapy

ConditionsRelapsed Follicular LymphomaRefractory Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biopsy proven relapsed or refractory CD20 positive, grade 1-3a follicular lymphoma (biopsy within 3 months of trial entry)

Aged 18 years or over

Advanced disease that in the opinion of the treating physician requires treatment

Patient suitable for standard available therapy at the Investigator's discretion

Disqualifiers

Current (or within 1 year) transformation to high grade lymphoma, including grade 3b follicular lymphoma (patients with historical high-grade transformation over 1 year ago are eligible)

Non-Fluorodeoxyglucose (FDG) avid disease

Prior allogenic stem cell transplantation (SCT) or solid organ transplant

Prior treatment with lenalidomide

Trial design

Design model

Sequential

Treatments tested in this trial

  • Epcoritamab

    Drug

    Bispecific antibody

  • Lenalidomide

    Drug

    Immunomodulatory agent

  • Rituximab

    Drug

    Monoclonal antibody

  • Obinutuzumab

    Drug

    Monoclonal antibody

  • Bendamustine

    Drug

    Alkylating agent (chemotherapy drug)

  • Vincristine

    Drug

    Antineoplastic, Vinca Alkaloid

  • Doxorubicin

    Drug

    Anthracycline

  • Cyclophosphamide

    Drug

    Alkylating agent (chemotherapy drug)

  • Prednisone

    Drug

    Corticosteroid

  • Investigation agent 2

    Drug

    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

  • Investigation agent 3

    Drug

    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

Treatment groups

284 Participants
are divided into 4 treatment groups
Group A: Round 1: Epcoritamab and lenalidomideExperimental treatment 2 interventions
Group B: Round 2Experimental treatment 1 intervention
Group C: Round 3Experimental treatment 1 intervention
Group D: All rounds: Investigator Choice TherapyActive comparator 8 interventions

Trial outcomes

Primary outcomes

1

Complete metabolic response (CMR)

CMR will be assessed by PET-CT using the Deauville 5-point scale and Lugano 2014 criteria. Patients who die from any cause or relapse/progress prior to this time-point will be considered non-responders. Patients who don't have a PET-CT scan within the protocol defined window or withdraw from the trial prior to this time-point will be considered non outcome evaluable. Patients who undergo stem-cell transplant (SCT) within 24 weeks of randomisation, patients who fail to start treatment and patients whose ineligibility is deemed to impact upon response to treatment will be replaced and hence not included in the analysis of this outcome

Time frame
24 weeks

Secondary outcomes

1

Overall metabolic response

Complete metabolic response (CMR) and partial metabolic response (PMR) will be assessed by PET-CT. Patients who die from any cause or relapse/progress prior to this time-point will be considered non-responders. Patients who undergo stem-cell transplant (SCT) within 24 weeks of randomisation, patients who fail to start treatment and patients whose ineligibility is deemed to impact upon response to treatment will be replaced and hence not included in the analysis of this outcome

Time frame
24 weeks
2

Progression free survival (PFS)

The time from randomisation to the date of first disease progression or death. Patients who are alive and relapse/progression at the time of analysis will be censored at their date last seen

Time frame
10 years
3

Overall survival (OS)

The time from randomisation to the date of death from any cause. Patients who are alive at the time of analysis will be censored at their date last seen

Time frame
10 years
4

Duration of response (DoR)

The time from complete and partial metabolic response by PET-CT to relapse/progression or death from any cause. Patients who are alive and relapse/progression free at the time of analysis will be censored at their date last seen

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Birmingham

Lead sponsor

Cancer Research UK

Collaborator

Genmab

Collaborator

Source ClinicalTrials.gov
Apply now