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.
What the study is about: This study will evaluate whether surovatamig, a novel CD19 × CD3 bispecific T-cell engager, can improve outcomes for people with previously untreated, limited-stage nodal follicular lymphoma (FL). The trial will compare surovatamig with the current standard of care: involved-site radiotherapy (ISRT) with or without rituximab. The aim is to determine whether surovatamig can produce deeper and more durable responses, reduce the risk of disease relapse, and improve event-free survival. Who is it for: This study is for adults aged 18 years or older who have: 1. Histologically confirmed classical follicular lymphoma (Grade 1-3a), Ann Arbor stage I or II nodal, non-bulky disease ( less or equal to 7 cm) 2. PET-positive, measurable disease 3. No prior lymphoma-directed therapy Study details: This is an international, Phase III randomised clinical trial. Participants will be randomised 1:1 on either Surovatamig (6 doses over 12 weeks with an additional triple step-up dosing schedule over 14 days for cycle 1) or to the standard of care treatment (Involved-Site Radiotherapy (24 Gy) with or without 6 doses of rituximab, according to each site's predefined standard). Participants will be followed up for 5 years after treatment to assess long-term outcomes. A total of 138 participants will be enrolled across Australia, New Zealand, the United Kingdom, Ireland and Nordic countries. What is hoped from it: If successful, surovatamig could represent a new standard of care for patients with early-stage nodal follicular lymphoma that is highly effective, well-tolerated, non-radiation frontline option for patients with limited-stage FL.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Surovatamig is supplied as a concentrate for solution for intravenous administration (2mg/mL).
24 Gray of ISRT
Involved-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
Determined by Lugano 2014 Response Criteria and audit of medical records
Time frame: Time from date of randomisation until disease progression until end of 5 year follow up.
Event Free Survival
As determined by the Lugano 2014 Response Criteria and audit of medical records
Time frame: Time from date of randomisation to death from any cause, initiation of new anti-lymphoma treatment or disease progression until end of 10 year follow up. Assessment will be performed at end of treatment, every 3 months in year 1, every 6 months in year 2
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