A Study Comparing a New Drug (Surovatamig) With Standard Radiotherapy With or Without Rituximab i… (NCT07736950) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study Comparing a New Drug (Surovatamig) With Standard Radiotherapy With or Without Rituximab in Adults With Limited Stage Nodal Follicular Lymphoma
138 participantsStarted 2027-01-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. Must have histologically confirmed classical follicular lymphoma (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 the World Health Organization (WHO) Classification of Haematolymphoid Tumours.
. Must have Ann Arbor Stage I or II, nodal, non-bulky disease (maximum tumour diameter less than or equal to 7 cm).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Event Free Survival
Timeframe: Time from date of randomisation until disease progression until end of 5 year follow up.
2
Event Free Survival
Timeframe: 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
. Previously untreated disease (no prior systemic lymphoma-directed therapies).
. Has one or more target lesions:
Exclusion criteria
. 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.
. Has had major surgery within 14 days prior to the first dose of trial intervention (excluding biopsies) or anticipation of the need for major surgery during trial intervention.
. Clinically significant cardiovascular disease, such as:
. Myocardial infarction within less or equal to 12 weeks or stroke within 6 months prior to randomisation
. Screening 12-lead electrocardiogram (ECG) showing a baseline QT interval as corrected by Frederica's formula (QTcF) over 480 msec