SOUNDTRACK-F1 Phase III study of AZD0486 with rituximab in previously untreated follicular lymphoma
Research type
Research Study
Full 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
IRAS ID
1010034
Contact name
Niloufar Davoudi
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Follicular lymphoma (FL) has standard treatments available, but they are not effective for some people and can cause severe side effects. Also, the cancer often returns after these standard treatments. The trial drug AZD0486 is designed to help the immune system recognize and kill lymphoma cells.
Rituximab (R) is an approved drug for treating FL that also helps the immune system kill lymphoma cells but is typically combined with chemotherapy. Researchers want to find out if AZD0486 combined with rituximab is safe and effective in treating newly diagnosed FL, and to compare it to standard chemotherapy combined with rituximab.
This AstraZeneca global trial has 2 parts. Participants may be enrolled in either part, but not both. In Part 1, participants with FL will receive different doses of AZD0486 to determine the safest dose when combined with rituximab, which will then become the recommended Phase 3 dose (RP3D) for part 2 of the study. In Part 2, participants will receive either AZD0486+R (experimental arms), or chemotherapy with R (control arm). Those randomly assigned to the experimental arms will receive AZD0486+R in one of 2 different schedules. Participants randomly assigned to the control arm will receive one of 3 standard chemotherapy regimens (R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) or R-CVP (rituximab, cyclophosphamide, vincristine, prednisone) followed by R maintenance, or BR (bendamustine, rituximab) which will be determined by your doctor.,.
During treatment, the study will regularly evaluate how well the lymphoma is responding to therapy while monitoring for side effects. After patients have completed treatment, participants will be followed to see if the cancer returns, and for survival status. This study involves blood and urine samples, questionnaires, medical imaging, bone marrow and tumor samples, and electrocardiograms.
Medical history and current medications will also be recorded.REC name
North West - Haydock Research Ethics Committee
REC reference
24/NW/0278
Date of REC Opinion
15 Nov 2024
REC opinion
Further Information Favourable Opinion