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A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Untreated Follicular Lymphoma

Interventions: Surovatamig, R-CHOP, R-CVP, BR

Countries: United States, Australia, Belgium, Brazil, Canada, China, Czechia, Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification
3. ECOG performance status of 0 to 2
4. No prior systemic lymphoma-directed therapy
5. Need for systemic treatment meeting at least 1 GELF criteria
6. FDG-avid and measurable disease
7. Stage II to IV and FLIPI 2-5 \[Phase III only\]
8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion Criteria:

1. 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
2. Contra-indication to BR, RCVP, and R-CHOP
3. Participants with or history of CNS lymphoma
4. 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
5. Presence of \>5000 circulating lymphoma cells
6. 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
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Locations (224)

Huntsville, Alabama, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Clovis, California, United States
Los Alamitos, California, United States
San Diego, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Evanston, Illinois, United States
Peoria, Illinois, United States
Fort Wayne, Indiana, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Ypsilanti, Michigan, United States
Saint Paul, Minnesota, United States
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