CA073-1022 - Evaluation of Golcadomide with Rituximab in ND FL Pts
Research type
Research Study
Full title
A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination with Rituximab in Participants with Newly Diagnosed Advanced Stage Follicular Lymphoma (GOLSEEK-2)
IRAS ID
1010204
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corp.
Clinicaltrials.gov Identifier
Research summary
This is a phase 2 multi-centre study of the investigational drug Golcadomide in adults with newly diagnosed advanced stage Follicular Lymphoma. The study will evaluate the effectiveness and safety of Golcadomide in combination with Rituximab or investigator’s choice of R-Chemotherapy such as Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or Bendamustine-Rituximab. Participants will be randomized between two dose levels of golcadomide (0.2mg or 0.4mg) in combination with Rituximab or investigator’s choice of R-Chemotherapy (R-CHOP or BR). Participants will receive the study drug until they withdraw consent their consent, or no longer tolerate the study drug, or their disease worsens. There is also the option of having rituximab maintenance after completion of Golcadomide and Rituximab or investigators choice of R-Chemotherapy. Golcadomide is taken orally and works with a protein called cereblon to destroy the pathways which are crucial for B-cell malignancy development. It results in an increase of T cells, Natural Killer Cells which are involved in the killing and death of B-cells. Approximately 90 participants will take part in the study world-wide with 16 taking part in the UK. Participants and their hospital doctor will know whether they are on the investigational Golcadomide and Rituximab or the investigators choice of R-Chemotherapy. During the study, participants will have the following procedures physical exams, heart scan (MUGA/ECHO), body scans (CT/MRI), bone marrow aspirate/biopsies, ECGs, vital signs (blood pressure, breathing rate and temperature), blood and urine sampling and pregnancy testing. After completion of the treatment period or discontinuing treatment due to disease progression, participants will be followed up every 6 months for up to 3 years from Last Participant First Visit date or end of study (whichever occurs first) for overall survival, subsequent disease progression and any later anti-lymphoma therapies
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0501
Date of REC Opinion
8 Aug 2024
REC opinion
Further Information Favourable Opinion