drugset / Trial / NCT07736950

A Study Comparing a New Drug (Surovatamig) With Standard Radiotherapy With or Without Rituximab in Adults With Limited Stage Nodal Follicular Lymphoma

NCT07736950 ↗

Phase 3 Not yet recruiting 140 enrolled Australasian Leukaemia and Lymphoma Group
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if surovatamig works better than standard of care involved-site radiotherapy (ISRT) with or without rituximab to treat patients with limited-stage follicular lymphoma. It will also learn about the safety of the drug. The main questions it aims to answer is whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival. Participants will: 1\) Take surovatamig for 4 cycles. The first cycle will have a dose ramp up in 3 steps over a period of 14 days. Cycle 2-4 are for 28 days with drug administered every fortnight. OR 2a) Undergo radiotherapy only for 3 weeks OR 2b) Radiotherapy + rituximab weekly for 6 doses (6 weeks) Visit the clinic once every cycle, at the end of treatment, and be monitored every 3 months in year 1, every 6 months in year 2, and once a year from year 3-5 for checkups and tests.

Timeline

Start
2027-01-12
Primary completion
2035-01-13
Completion
2035-01-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Surovatamig Protein / enzyme biologic 7.2 mg Intravenous

Indications