Overview
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.
Description
The study consists of 2 sequential parts.
- Safety Run-in - this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D.
- Phase III - The Phase III part will assess the superiority of AZD0486 at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms
- Arm A: treatment with AZD0486 plus rituximab Schedule A
- Arm B: treatment with AZD0486 plus rituximab Schedule B
- Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance and B-R + rituximab maintenance
Eligibility
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
- 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