Last updated 8 days ago
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
1015 patients around the world
Available in Brazil, Belgium
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
1. Arm A: treatment with AZD0486 plus rituximab Schedule A
2. Arm B: treatment with AZD0486 plus rituximab Schedule B
3. 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
AstraZeneca
1015Patients around the world
This study is for people with
Non-Hodgkin Lymphoma
Follicular lymphoma
Requirements for the patient
To 130 Years
All Gender
Medical requirements
- 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.Adequate liver, hematological, renal and cardiac function.
- 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.
SponsorAstraZeneca
Study typeInterventional
Conditions
Follicular lymphoma
Requirements
To 130 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06549595
