CA0731003 Comparison of Golcadomide + Rituximab vs SoC in RR FL
Research type
Research Study
Full title
A Phase 3,Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination with Rituximab (Golca + R) Vs Investigator’s Choice in Participants with Relapsed/Refractory Follicular Lymphoma (GOLSEEK-4)
IRAS ID
1009224
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corp.
Eudract number
2024-519152-82
Research summary
This is a phase 3, multicentre study of the investigational drug golcadomide in adults with follicular lymphoma that has returned or not responded to treatment after at least one prior systemic therapy. The study will evaluate the effectiveness and safety of golcadomide in combination with rituximab or investigator’s choice of R-lenalidomide or R-chemotherapy (R-CHOP or R-Bendamustine).
Participants will be randomised equally between golcadomide in combination with rituximab or investigator’s choice. Participants will receive the study drug until they withdraw consent their consent, or treatment is not well-tolerated, or their disease worsens.
Golcadomide is a new oral drug being studied for the treatment of various types of blood cancers, including follicular lymphoma. This medication is part of a class of drugs called Cereblon E3 Ligase Modulators or CELMoD for short. Golcadomide works by targeting specific proteins in cancer cells, including a protein called cereblon. By affecting these proteins golcadomide disrupts the survival and growth of cancer cells. Golcadomide also helps the immune system work better, making it more effective at finding and attacking cancer cells.
Approximately 400 participants will take part in the study world-wide with 12 taking part in the UK. Participants and their hospital doctor will know whether they are on golcadomide and rituximab or the investigators choice of R-lenalidomide or R-chemotherapy.
During the study, participants will have the following procedures: medical examinations, heart scan (MUGA/ECHO), body scans (CT; MRI; FDG PET-CT), bone marrow aspirate/biopsies, ECGs, vital signs, blood, saliva and tissue sampling and pregnancy testing. After completion of the treatment period or discontinuation of treatment due to disease progression, participants will be followed up for up to 5 years or end of study (whichever occurs first) for overall survival, subsequent disease progression and any later anti-lymphoma therapies.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0290
Date of REC Opinion
20 Jun 2025
REC opinion
Further Information Favourable Opinion