SOUNDTRACK-B
Research type
Research Study
Full title
A Modular Phase II, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
IRAS ID
1011238
Contact name
Assim Khan
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
Follicular lymphoma (FL) and Diffuse Large B-cell lymphoma (DLBCL) have standard treatments available, but they are not effective for some people and can cause severe side effects. Also, the cancer may return after these standard treatments.
The trial drug AZD0486 is designed to help the immune system recognize and kill lymphoma cells. Researchers want to find out if the AZD0486 dose identified can control FL and DLBCL that have returned or gotten worse after at least 2 prior anti-cancer treatments. It is also to evaluate if AZD0486 prevents the lymphoma from worsening and if it is safe. Participants must not have any other types of
blood cancer or other serious medical conditions.This AstraZeneca global trial has 2 parts also called modules:
Part 1, participants with FL will receive AZD0486 monotherapy for a period of up to 2 years. In Part 2, participants with DLBCL will also receive AZD0486 monotherapy for up to 1 year. During treatment, the study will evaluate how well the lymphoma is responding to therapy with AZD0486, while monitoring for side effects. In both parts, AZD0486 will be given as a 2-hour infusion into the vein. After the participants finish treatment, the trial doctors will follow up with them for up to 4 more years to check their health and cancer status.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 tumour samples, and electrocardiograms. Medical history and current medications will also be recorded.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0026
Date of REC Opinion
21 Mar 2025
REC opinion
Further Information Favourable Opinion