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

NCT07736950 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: ALLG NHL45ACTRN12626000311358
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

  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 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

Study Arms (3)

Arm A (Investigational arm): Surovatamig

ACTIVE COMPARATOR

This arm involves treatment with Surovatamig only with no radiotherapy. Treatment is in 3 phases. 1. Cycle 1 is a 14 day cycle including a triple step-up dosing: Day 1 of cycle 1: 0.09 mg, Day 4 of cycle 1: 0.27 mg, Day 8 of cycle 1: 1.0 mg. 2. Cycle 2-4 are 28 day cycles with a dose administered every 2 weeks: Cycles 2-4 (28-day cycle): Surovatamig treatment doses administered on days 1 and 15 of each cycle at 7.2mg. 3\. At the end of cycle 4, patients will enter the post-treatment period.

Drug: Surovatamig

Arm B1: Involved-Site Radiotherapy (ISRT) 24Gy

ACTIVE COMPARATOR

This arm is the standard of care (SOC): Involved-Site Radiotherapy (ISRT) at 24Gy and involves radiotherapy for 3 weeks.

Radiation: Involved Site Radiotherapy (ISRT)

Arm B2: Involved-Site Radiotherapy (ISRT) 24Gy + rituximab x 6 cycles

ACTIVE COMPARATOR

This arm is another standard of care (SOC): 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.

Radiation: Involved-Site Radiotherapy (ISRT) + Rituximab

Interventions

Surovatamig DRUG

Surovatamig is supplied as a concentrate for solution for intravenous administration (2mg/mL).

Arm A (Investigational arm): Surovatamig

Involved Site Radiotherapy (ISRT) RADIATION

24 Gray of ISRT

Arm B1: Involved-Site Radiotherapy (ISRT) 24Gy

Involved-Site Radiotherapy (ISRT) + Rituximab RADIATION

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.

Arm B2: Involved-Site Radiotherapy (ISRT) 24Gy + rituximab x 6 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Must have Ann Arbor Stage I or II, nodal, non-bulky disease (maximum tumour diameter ≤7cm)
• Previously untreated disease (no prior systemic lymphoma-directed therapies)
• Has one or more target lesions:
• A PET/CT scan demonstrating PET-positive lesion(s), and
• ≥ 1 measurable nodal lesion (long axis \> 1.5cm) on CT scan or MRI
• ECOG performance status 0-2
• Patient must have adequate haematologic function:
• ANC ≥ 1.0 x 10\^9/L
• Haemoglobin ≥ 90 g/L
• Platelet count ≥ 100 x 10\^9/L
• Patient must have adequate renal and liver function, unless values meeting the following criteria are related to lymphoma):

You may not qualify if:

• 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.
• Prior exposure to surovatamig or a history of severe allergic or anaphylactic reactions to any component or excipient of surovatamig
• Has had major surgery within 14 days prior to the first dose of trial intervention (excluding biopsies) pr anticipation of the need for major surgery during trial intervention
• Relative contraindications for radiotherapy
• Non-rheumatoid collagen vascular disorders involving the potential radiation field
• Radiation field that may impact on Cardiac implantable electronic devices (CIEDs).
• Previous radiation therapy to the same site.
• Clinically significant cardiovascular disease, such as:
• Myocardial infarction within ≤ 12 weeks or stroke within 6 months prior to randomisation
• Screening 12-lead ECG showing a baseline QT interval as corrected by Frederica's formula (QTcF) \> 480 msec
• The following conditions within 3 months prior to randomisation:
• i. Uncontrolled unstable angina ii. New York Heart Association (NYHA) Class III-IV congestive heart failure iii. Uncontrolled life-threatening cardiac arrhythmia iv. Other clinically significant ECG abnormalities in the opinion of the investigator

Sponsors & Collaborators

• Australasian Leukaemia and Lymphoma Group: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chan Cheah

  Sir Charles Gairdner Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): January 12, 2027
• Primary Completion (Estimated): January 13, 2035
• Study Completion (Estimated): January 13, 2035
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share