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

Study acronym: RAZOR
StatusNot Yet Recruiting
PhasePhase 3
Started

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Record History

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  1. Minor Enrollment target: 138 to 140
    • Eligibility criteria expanded, about 431 words
    • Study description expanded, about 3 words
  2. Minor Interventions: Surovatamig (Drug) to Involved Site Radiotherapy (ISRT) (Radiation), Involved-Site Radiotherapy (ISRT) + Rituximab (Radiation), Surovatamig (Drug)
    • Study title shortened, about 3 words
    v2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07736950
Lead Sponsor Australasian Leukaemia and Lymphoma Group
Conditions
(from sponsor)
Follicular Lymphoma
Related terms Lymphoma, Follicular
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov