Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

284

participants targeted

Target at P75+ for phase_2

Timeline

67mo left

Started Sep 2023

Longer than P75 for phase_2

Geographic Reach

1 country

25 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.2 years study duration

Study Progress32%

Sep 2023Nov 2031

First Submitted

Initial submission to the registry

April 18, 2023

Completed

20 days until next milestone

First Posted

Study publicly available on registry

May 8, 2023

Completed

4 months until next milestone

Study Start

First participant enrolled

September 4, 2023

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2029

Expected

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2031

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

5.7 years

First QC Date

April 18, 2023

Last Update Submit

April 29, 2026

Conditions

Relapsed Follicular Lymphoma Refractory Follicular Lymphoma

Keywords

EpcoritamabLymphoma

Outcome Measures

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
24 weeks

Secondary Outcomes (9)

Overall metabolic response
24 weeks
Progression free survival (PFS)
10 years
Overall survival (OS)
10 years
Duration of response (DoR)
10 years
Duration of complete response (DoCR)
10 years
+4 more secondary outcomes

Study Arms (4)

Round 1: Epcoritamab and lenalidomide

EXPERIMENTAL

Epcoritamab (weekly for cycles 1 and 2 and on day 1 of cycles 3-12 for up to 12 cycles) and lenalidomide (daily for days 1-21 of each cycle for up for 12 cycles), cycles will be 28 day cycles.

Drug: EpcoritamabDrug: Lenalidomide

Round 2

EXPERIMENTAL

Investigation agent 2

Drug: Investigation agent 2

Round 3

EXPERIMENTAL

Investigation agent 3

Drug: Investigation agent 3

All rounds: Investigator Choice Therapy

ACTIVE COMPARATOR

Choice of therapy to be selected by the Investigator for each patient prior to randomisation. The Investigator will choose between; RCHOP, RCVP, rituximab and bendamustine, rituximab and lenalidomide or bendamustine and obinutuzumab.

Drug: LenalidomideDrug: RituximabDrug: ObinutuzumabDrug: BendamustineDrug: VincristineDrug: DoxorubicinDrug: CyclophosphamideDrug: Prednisone

Interventions

EpcoritamabDRUG

Bispecific antibody

Round 1: Epcoritamab and lenalidomide

LenalidomideDRUG

Immunomodulatory agent

All rounds: Investigator Choice TherapyRound 1: Epcoritamab and lenalidomide

RituximabDRUG

Monoclonal antibody