Brief Summary
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.
Detailed Description
The study consists of 2 sequential parts.
- Safety Run-in – this part will compare dosethe amount of medication taken 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
Intervention / Treatment
- Drug: AZD0486
- Drug: R-CHOP
- Drug: R-CVP
- Drug: BR
Inclusion Criteria:
- Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- Histologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results 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.