First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma
This study will involve participants with a condition called Follicular Non Hodgkin Lymphoma (Follicular Lymphoma). The main purpose of this study is to see if it is safe to give an induction schedule of the drug golcadomide, in combination with Rituximab +/- Nivolumab, and to see how effective this combination is in patients who have had no previous drug treatment for their lymphoma. In particular, we will be monitoring for any specific side effects which may be increased by adding golcadomide to Rituximab treatment +/- Nivolumab for 8 cycles (28 days per cycle), with up to 2 years of maintenance treatment of rituximab in eligible patients following induction. Participants will be reviewed at baseline and prior to each cycle of treatment for toxicity, scans will be performed at baseline, after 2 and 5 cycles of induction treatment, and every 8 weeks during maintenance phase. Following completion of treatment, participants will be followed up for a total of 3 years (every 6 months). In participants with relapsed disease, these will be followed for survival every 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
BMS-986369 is an orally administered Cereblon-modulating compound
Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.
Rituximab is a chimeric anti-CD20 antibody containing human IgG lambda and kappa constant regions with murine variable regions
Grampians Health
Ballarat, Victoria, Australia
Eastern Health
Box Hill, Victoria, Australia
University Hospital Geelong, Barwon Health
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Proportion of patients who achieve a complete metabolic response in the absence of prohibitive toxicity with induction rituximab, golcadomide with or without nivolumab comprising 8 cycles of therapy with each cycle delivered every 4 weeks.
Metabolic response as assessed by PET/CT and defined by Lugano criteria; toxicities as defined by CTCAE v5
Time frame: Consent to 8 weeks after last induction treatment (maximum 44 weeks)
To assess overall toxicity
As determined by rate of toxicity grade 3 or higher per CTCAE V5
Time frame: Day 1 to 30 days after the end of maintenance phase (up to maximum 32 months)
To assess time to treatment failure
Treatment response assessed by PET/CT according to the Lugano classification for Response Criteria for Non-Hodgkin Lymphoma
Time frame: Day 1 end of follow up period (up to a maximum of 5 years)
Progression free survival
Quantification of progression free survival
Time frame: Day 1 end of follow up period (up to a maximum of 5 years)
Overall survival
Quantification of OS
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
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Fiona Stanley Hospital
Perth, Western Australia, Australia