Finding studies
Finding studies
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Lead
Australasian Leukaemia and Lymphoma Group
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 140 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
