Status:
RECRUITING
A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Lead Sponsor:
AstraZeneca
Conditions:
Untreated Follicular Lymphoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 - T...
Eligibility Criteria
Inclusion
- Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- ECOG performance status of 0 to 2
- No prior systemic lymphoma-directed therapy
- Need for systemic treatment meeting at least 1 GELF criteria
- FDG-avid and measurable disease
- Stage II to IV and FLIPI 2-5 \[Phase III only\]
- Adequate liver, hematological, renal and cardiac function.
- The above is a summary, other inclusion criteria details may apply
Exclusion
- Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
- Contra-indication to BR, RCVP, and R-CHOP
- Participants with or history of CNS lymphoma
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
- Presence of \>5000 circulating lymphoma cells
- Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)
- The above is a summary, other exclusion criteria details may apply
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 26 2031
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT06549595
Start Date
August 7 2024
End Date
November 26 2031
Last Update
February 17 2026
Active Locations (131)
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1
Research Site
New York, New York, United States, 10032
2
Research Site
New York, New York, United States, 10065
3
Research Site
Nashville, Tennessee, United States, 37203
4
Research Site
Garran, Australia, 2605