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Clinical Trials in India / NCT06549595
Recruiting Phase 3

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

NCT06549595 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-08-07
Last updated
2026-08-19

Condition(s) studied

Untreated Follicular Lymphoma

Investigational drug(s) / intervention(s)

SurovatamigR-CHOPR-CVPBR

Surovatamig: a fully human bispecific monoclonal IgG4 antibody

R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone

R-CVP: Rituximab, Cyclophosphamide, Vincristine and Prednisone

BR: Bendamustine, Rituximab

Study 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 to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (228)

FacilityCityRegionStatus
Research Site Huntsville Alabama Not Yet Recruiting
Research Site Anchorage Alaska Recruiting
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Clovis California Not Yet Recruiting
Research Site Los Alamitos California Not Yet Recruiting
Research Site San Diego California Not Yet Recruiting
Research Site Santa Monica California Not Yet Recruiting
Research Site Aurora Colorado Withdrawn
Research Site New Haven Connecticut Not Yet Recruiting
Research Site Newark Delaware Not Yet Recruiting
Research Site Jacksonville Florida Not Yet Recruiting
Research Site Atlanta Georgia Not Yet Recruiting
Research Site Macon Georgia Not Yet Recruiting
Research Site Evanston Illinois Not Yet Recruiting
Research Site Peoria Illinois Not Yet Recruiting
Research Site Fort Wayne Indiana Not Yet Recruiting
Research Site Des Moines Iowa Not Yet Recruiting
Research Site Iowa City Iowa Not Yet Recruiting
Research Site Lexington Kentucky Not Yet Recruiting
Research Site Louisville Kentucky Not Yet Recruiting
Research Site Baton Rouge Louisiana Not Yet Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Bethesda Maryland Not Yet Recruiting
Research Site Columbia Maryland Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Ann Arbor Michigan Not Yet Recruiting
Research Site Detroit Michigan Withdrawn
Research Site Ypsilanti Michigan Not Yet Recruiting
Research Site Saint Paul Minnesota Not Yet Recruiting
Research Site Chesterfield Missouri Not Yet Recruiting
Research Site Springfield Missouri Not Yet Recruiting
Research Site Hackensack New Jersey Not Yet Recruiting
Research Site New Brunswick New Jersey Not Yet Recruiting
Research Site Albany New York Not Yet Recruiting
Research Site New Hyde Park New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site Charlotte North Carolina Not Yet Recruiting

+ 188 more sites — see the full list on the official registry below.

More AstraZeneca trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06549595 on ClinicalTrials.gov ↗ ← All trials in India