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

Sponsor
Australasian Leukaemia and Lymphoma Group
Study ID
NCT07736950
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surovatamig — DRUG
    Surovatamig is supplied as a concentrate for solution for intravenous administration (2mg/mL).
  • Involved Site Radiotherapy (ISRT) — RADIATION
    24 Gray of ISRT
  • 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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Jan 12, 2027
Status verified
Aug 2026
Primary completion
Jan 13, 2035
Completion
Jan 13, 2035

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (Investigational arm): Surovatamig
    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.
  • Active Comparator: Arm B1: Involved-Site Radiotherapy (ISRT) 24Gy
    This arm is the standard of care (SOC): Involved-Site Radiotherapy (ISRT) at 24Gy and involves radiotherapy for 3 weeks.
  • Active Comparator: Arm B2: Involved-Site Radiotherapy (ISRT) 24Gy + rituximab x 6 cycles
    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.

Primary Outcome Measure

Event Free Survival [ Time Frame: Time from date of randomisation until disease progression until end of 5 year follow up. ]

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