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.
Patients or their legally authorised representative must voluntarily sign and date an informed consent form (ICF), approved by a Human Research Ethics Committee (HREC), prior to the initiation of any screening or trial-specific procedures.
Provide samples for optional genetic research that supports the Genomic Initiative.
Are willing and able to comply with procedures required in this protocol.
Age 18 years and older at the time of signing the informed consent form (ICF).
Has a history of prior systemic or radiotherapy therapy for follicular lymphoma (FL).
Has prior or current follicular large B-cell lymphoma (World Health Organization [WHO] 2022 classification), formerly follicular lymphoma Grade 3B (WHO 2016 classification), histologic transformation to diffuse large B-cell lymphoma (DLBCL) or other aggressive lymphomas.
Known or suspected central nervous system (CNS) involvement at screening based on clinical presentation or imaging findings.
A history of severe allergic or anaphylactic reactions to any component or excipient of AZD486.