A study of AZD0486 plus Rituximab in previously untreated Follicular Lymphoma patients

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.

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