At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Surovatamig (drug), R-CHOP (drug), R-CVP (drug), BR (drug)
- How long the study runs
- Study runs about 87 months (dates as stated)
- About the drug or intervention
- Surovatamig — drug: a fully human bispecific monoclonal IgG4 antibody · R-CHOP — drug: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone · R-CVP — drug: Rituximab, Cyclophosphamide, Vincristine and Prednisone · BR — drug: Bendamustine, Rituximab
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 130 Years
- Who
- All
- Number of participants
- 1,018
- Started
- 2024-08-07
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for untreated follicular lymphoma
- • Phase3 - 1,018 participants
- • This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL
Who can take part?
- • Ages 18 Years to 130 Years
- • Diagnosed with untreated follicular lymphoma
Where?
- • London - Research Site
- • London - Research Site
- • Newcastle upon Tyne - Research Site
- • Norwich - Research Site
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
More detail
The study consists of 2 sequential parts. 1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D. 2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms 1. Arm A: treatment with Surovatamig plus rituximab Schedule A 2. Arm B: treatment with Surovatamig plus rituximab Schedule B 3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 130 Years
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
What the study is looking for
- ✓Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- ✓confirmed by a biopsy diagnosis of classic FL per WHO 2022 classification
- ✓Fit enough for normal activity (ECOG 0) to 2
- ✓No prior systemic lymphoma-directed therapy
- ✓Need for systemic treatment meeting at least 1 GELF criteria
Who cannot take part
- ✗Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016...
- ✗Contra-indication to BR, RCVP, and R-CHOP
- ✗Participants with or history of CNS lymphoma
- ✗Presence of \>5000 circulating lymphoma cells
- ✗Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
See the full criteria
Where Is This Study? (7 UK sites)
Research Site
London EC1M6BQ, United Kingdom
Research Site
London SE5 9RS, United Kingdom
Research Site
Newcastle upon Tyne NE7 7DN, United Kingdom
Research Site
Norwich NR4 7UY, United Kingdom
Research Site
Nottingham NG5 1PB, United Kingdom
Research Site
Plymouth PL6 8DH, United Kingdom
Research Site
Southampton SO16 6YD, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
