Study identifier:D7401C00001
ClinicalTrials.gov identifier:NCT06549595
EudraCT identifier:N/A
CTIS identifier:2023-510098-33-00
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)
untreated Follicular Lymphoma
Phase 3
No
AZD0486, R-CHOP, R-CVP, BR
All
1015
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
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.
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 a. Arm A: treatment with AZD0486 plus rituximab Schedule A b. Arm B: treatment with AZD0486 plus rituximab Schedule B c. 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
Location
Status
Location
Barcelona, Spain, 8036
Status
Not yet recruiting
Location
Gliwice, Poland, 44-102
Status
Not yet recruiting
Location
Madrid, Spain, 28040
Status
Not yet recruiting
Location
Oviedo, Spain, 33011
Status
Not yet recruiting
Location
Pamplona, Spain, 31008
Status
Not yet recruiting
Location
Barcelona, Spain, 08035
Status
Not yet recruiting
Location
Madrid, Spain, 28041
Status
Not yet recruiting
Location
El Palmar, Spain, 30120
Status
Not yet recruiting
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 |
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