A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
NCT Number: NCT06549595
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Untreated Follicular Lymphoma
Interventions: DRUG: AZD0486|DRUG: R-CHOP|DRUG: R-CVP|DRUG: BR
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1005
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2035-03-01
Locations: Research Site, Macquarie University, 2109, Australia|Research Site, Nedlands, 6009, Australia|Research Site, Brussels, 1090, Belgium|Research Site, Brussel, 1000, Belgium|Research Site, Gent, 9000, Belgium|Research Site, Mechelen, 2800, Belgium|Research Site, Hamilton, Ontario, L8V 5C2, Canada|Research Site, Oshawa, Ontario, L1G 2B9, Canada|Research Site, Chicoutimi, Quebec, G7H 5H6, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Beijing, 100142, China|Research Site, Tianjin, 300020, China|Research Site, Helsinki, 00029, Finland|Research Site, Tampere, 33521, Finland|Research Site, Seoul, 05505, Korea, Republic of|Research Site, Seoul, 06351, Korea, Republic of|Research Site, Seoul, 13620, Korea, Republic of|Research Site, Gliwice, 44-102, Poland|Research Site, Barcelona, 08035, Spain|Research Site, Barcelona, 8036, Spain|Research Site, El Palmar, 30120, Spain|Research Site, Girona, 17007, Spain|Research Site, Las Palmas de Gran Canaria, 35020, Spain|Research Site, Madrid, 28040, Spain|Research Site, Madrid, 28041, Spain|Research Site, Oviedo, 33011, Spain|Research Site, Pamplona, 31008, Spain|Research Site, Santander, 39008, Spain|Research Site, Falun, 79182, Sweden|Research Site, Uppsala, 75185, Sweden|Research Site, Changhua, 50006, Taiwan|Research Site, Kaohsiung City, 80756, Taiwan|Research Site, Kaohsiung city, 833, Taiwan|Research Site, Lukang Township, 505029, Taiwan|Research Site, Tainan City, 704, Taiwan|Research Site, Taipei City, 106, Taiwan|Research Site, Ankara, 06620, Turkey|Research Site, Ankara, 6200, Turkey|Research Site, London, EC1M6BQ, United Kingdom

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.

Primary Outcome Measures: SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs, Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures., Up to 10 years|SRI Primary: Determination of the recommended Phase III dose (RP3D), The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the safety run-in part, Up to 1 year|Phase 3 Primary: To demonstrate the superiority of AZD0486 plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy, PFS, based on Lugano 2014 Response Criteria, as assessed by BICR., Up to 10 years
Secondary Outcome Measures: Safety Run in and Phase 3: ORR, ORR defined as the proportion of participants achieving either a PR or CR at any time based on Lugano 2014 Response Criteria, Up to 10 years|Safety Run In and Phase 3: CR Rate, CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria, Up to 10 years|Safety Run In and Phase 3: CR at EoI, Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria, Up to 10 years|Safety Run In and Phase 3: DoR, DoR will be defined as the time from the time of first response until progression based on Lugano 2014 criteria, up to 10 years|Safety Run In and Phase 3: PFS, PFS is defined as time until disease progression based on Lugano 2014 Response Criteria, Up to 10 years|Safety Run In and Phase 3: OS, OS is defined as time until the date of death, Up to 10 years|Phase 3: CR rate at 30 months, Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria, Up to 10 Years