A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 plus Rituximab versus Chemotherapy plus Rituximab in Previously Untreated Participants with Follicular Lymphoma (SOUNDTRACK-F1)
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.
Follicular Lymphoma
The study consists of 2 sequential parts. 1. Safety Run-in – this part will compare dose levels of AZD0486 in combination with rituximab in order to establish the RP3D. 2. 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 a. Arm A: treatment with AZD0486 plus rituximab Schedule A b. Arm B: treatment with AZD0486 plus rituximab Schedule B c. 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
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 FL Grades 1-3A per WHO 2016 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. Adequate liver, hematological, renal and cardiac function.
- The above is a summary, other inclusion criteria details may apply
Exclusion Criteria
- 1. 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. Presence of >5000 circulating lymphoma cells
- 5. 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
Professor Chan Cheah
AstraZeneca
Phase 2
D7401C00001