This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the AZD0486 plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL. (SOUNDTRACK-F1)

Astrazeneca K.K0 sites109 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Astrazeneca K.K
Enrollment: 109
Primary Endpoint: Safety and tolerability of AZD0486 plus rituximab
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

jrct.mhlw.go.jp

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Study Design

Parallel Assignment

Sex

All

Investigators

Sponsor

Astrazeneca K.K

Eligibility Criteria

Inclusion Criteria

•Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
•Histologically confirmed diagnosis of FL Grades 1-3A per WHO 2016 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
•Adequate liver, hematological, renal and cardiac function.
•The above is a summary, other inclusion criteria details may apply

Exclusion Criteria

•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
•Presence of >5000 circulating lymphoma cells
•Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study
•The above is a summary, other exclusion criteria details may apply

Outcomes

Primary Outcomes

Safety and tolerability of AZD0486 plus rituximab

Incidence, nature, and severity of AEs and SAEs based on NCI CTCAE v5.0/ASTCT and changes in laboratory data and vital signs compared with baseline. Incidence and nature of study intervention discontinuations, dose reductions, and dose delays due to AEs.

Progression-free survival (PFS)

PFS is defined as time from date of randomisation until disease progression, or death due to any cause, whichever comes first, based on Lugano 2014 Response Criteria, as assessed by BICR.