Treatment Of Newly-diagnosed Follicular Lymphoma With CELMoD Golcadomide, Rituximab +/- Nivolumab.

Conditions

• Follicular Lymphoma Stage II
• Follicular Lymphoma Stage III
• Follicular Lymphoma Stage IV

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• golcadomide — DRUG
  BMS-986369 is an orally administered Cereblon-modulating compound
• Nivolumab 10 MG/ML — DRUG
  Nivolumab is a fully humanised IgG4 blocking monoclonal antibody against PD-1.
• Rituximab — DRUG
  Rituximab is a chimeric anti-CD20 antibody containing human IgG lambda and kappa constant regions with murine variable regions

Study Details

First line treatment with combination rituximab and golcadomide with, or without nivolumab, in patients in previously untreated Follicular Lymphoma

Key Dates

Start date

Aug 31, 2023

Status verified

Jul 2025

Primary completion

Jan 1, 2027

Completion

Jun 1, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A- Golcadomide + Rituximab
  Rituximab 375mg/m2 IV infusion Q4W + golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction
• Experimental: Arm B- Nivolumab + golcadomide + Rituximab
  Nivolumab 480mg IV infusion Q4W, Rituximab 375mg/m2 IV infusion Q4W and golcadomide 0.4mg po D1-D14 of each cycle for 8 cycles, followed by Rituximab 375mg/m2 IV infusion Q12W in participants with CR/PR at end of induction

Primary Outcome Measure

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. [ Time Frame: Consent to 8 weeks after last induction treatment (maximum 44 weeks) ]