Status:
RECRUITING
A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
Lead Sponsor:
AstraZeneca
Conditions:
Untreated Follicular Lymphoma
Eligibility:
All Genders
18-130 years
Phase:
PHASE3
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 Investigato...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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 \[Phase III only\]
- Adequate liver, hematological, renal and cardiac function.
- The above is a summary, other inclusion criteria details may apply
Exclusion
- 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
- The above is a summary, other exclusion criteria details may apply
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 26 2031
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT06549595
Start Date
August 7 2024
End Date
November 26 2031
Last Update
December 4 2025
Active Locations (121)
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1
Research Site
Garran, Australia, 2605
2
Research Site
Heidelberg, Australia, 3084
3
Research Site
Macquarie University, Australia, 2109
4
Research Site
Nedlands, Australia, 6009