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A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Trial Status: active
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.
Inclusion Criteria
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 Criteria
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06549595.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Approved
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Approved
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
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