A study of AZD0486 plus Rituximab in previously untreated Follicular Lymphoma patients
Study identifier:D7401C00001
ClinicalTrials.gov identifier:NCT06549595
EudraCT identifier:N/A
CTIS identifier:2023-510098-33-00
Recruiting
Official Title
A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 plus Rituximab versus Chemotherapy plus Rituximab in Previously Untreated Participants with Follicular Lymphoma (SOUNDTRACK-F1)
Medical condition
untreated Follicular Lymphoma
Phase
Phase 3
Healthy volunteers
No
Study drug
AZD0486, R-CHOP, R-CVP, BR
Sex
All
Estimated Enrollment
1005
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 07 Aug 2024
Estimated Primary Completion Date: 15 Apr 2031
Estimated Study Completion Date: 28 Feb 2035
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Rituximab, AZD0486 - A AZD0486 regimen A plus rituximab | Drug: AZD0486 a fully human bispecific monoclonal IgG4 antibody Other Name: NA |
| Experimental: Rituximab, AZD0486 – B AZD0486 regimen B plus rituximab | Drug: AZD0486 a fully human bispecific monoclonal IgG4 antibody Other Name: NA |
| Active Comparator: Chemoimmunotherapy Investigator’s choice between 3 standard immunochemotherapy regimen (R-CHOP or R-CVP followed by rituximab maintenance, or B-R) | Drug: R-CHOP Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone Drug: R-CVP Rituximab, Cyclophosphamide, Vincristine and Prednisone Drug: BR Bendamustine, Rituximab |
Contacts
Investigators
Principal Investigator
Chan Cheah
Sir Charles Gairdner Hospital (SCGH)
