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, approved by an HREC, prior to the initiation of any screening or trial specific procedures.
Are willing and able to comply with procedures required in this protocol.
Age 18 years and older at the time of signing the ICF
Must have histologically confirmed classical FL (previously Grade 1 to 3a FL) at the most recent representative tumour biopsy based on the local pathology report, according to the 5th edition of WHO Classification of Haematolymphoid Tumours (excluding cutaneous and duodenal FL).
Has a history of prior systemic therapy or radiotherapy for FL.
Has prior or current Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification), histologic transformation to DLBCL or other aggressive lymphomas.
Inadequately staged follicular lymphoma (unable to perform staging imaging or bone marrow trephine length totalling <20mm)
Known or suspected CNS involvement at screening based on clinical presentation or imaging findings.
Parallel
Surovatamig
DrugSurovatamig is supplied as a concentrate for solution for intravenous administration (2mg/mL).
Involved Site Radiotherapy (ISRT)
Radiation24 Gray of ISRT
Involved-Site Radiotherapy (ISRT) + Rituximab
RadiationInvolved-Site Radiotherapy (ISRT) at 24Gy with 6 doses of rituximab administered weekly by intravenous (IV) at 375 mg/m\^2. 1 week = 1 cycle.
Event Free Survival
Defined as death from any cause, failure to achieve complete response (CR) at End-of-Treatment ((EoT); defined as 18 weeks from start of treatment), initiation of new anti-lymphoma treatment (including new RT) or disease progression (based on Lugano 2014 Response Criteria), whichever comes first
Event Free Survival
As determined by the Lugano 2014 Response Criteria and audit of medical records
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This trial is not recruiting at the moment. You can still explore other options:
