AZD0486 + R-mini-CHOP for Non-Hodgkin's Lymphoma
(SOUNDTRACK-D2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for individuals with a type of non-Hodgkin's lymphoma called LBCL. Researchers aim to determine if using AZD0486, an experimental treatment, after a shorter course of the current treatment (R-mini-CHOP) is more effective and safer than extending the current treatment. The trial explores different combinations of these treatments to identify the best approach. It seeks adults, particularly those who are older or have other health issues that make them unsuitable for stronger treatments, who have been newly diagnosed with LBCL and have measurable disease. Participants will try one of the treatment plans to evaluate its effectiveness. As a Phase 3 trial, this study serves as the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressive therapy for an active autoimmune or inflammatory condition, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD0486, whether used alone or with other cancer treatments, is well tolerated by patients. In one study involving patients whose conditions had returned or did not respond to treatment, AZD0486 was generally well tolerated, with most patients not experiencing severe side effects.
In earlier testing phases, patients experienced mild to moderate side effects, common with cancer treatments, but these were usually manageable. The study's progression to a later phase indicates that earlier results demonstrated the treatment's safety.
R-mini-CHOP, a combination of chemotherapy drugs, is already used to treat certain types of lymphoma. It is effective and has a well-understood safety profile, meaning doctors are familiar with its side effects and how to manage them.
Overall, earlier research has shown promise for AZD0486 combined with R-mini-CHOP, with safety profiles indicating that side effects are generally tolerable for patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD0486 combined with R-mini-CHOP for treating Non-Hodgkin's Lymphoma because it offers a novel approach to tackling the disease. Unlike the standard R-mini-CHOP regimen, which is a chemotherapy cocktail, AZD0486 is a new class of treatment that may target the cancer cells more precisely, potentially increasing effectiveness and reducing side effects. Additionally, the combination aims to enhance the body's ability to fight the lymphoma by utilizing the strengths of both therapies, offering hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for Non-Hodgkin's Lymphoma?
In this trial, participants will receive either R-mini-CHOP alone or in combination with AZD0486. Research has shown that combining AZD0486 with R-mini-CHOP holds promise for treating Non-Hodgkin's Lymphoma. Earlier studies found that AZD0486 was effective and safe for patients whose lymphoma had returned or did not respond to treatment. Specifically, one study demonstrated that this combination was effective in 36% to 91% of cases where the cancer recurred after treatment. R-mini-CHOP is already a well-known treatment for this type of lymphoma, making it a suitable partner for AZD0486. Overall, this combination therapy shows potential, especially for patients who have not responded to previous treatments.12346
Who Is on the Research Team?
Michael Dickinson,, MBBS BS DMSc
Principal Investigator
Peter MacCallum Cancer Center
Are You a Good Fit for This Trial?
This trial is for elderly or unfit patients newly diagnosed with LBCL, a type of Non-Hodgkin's Lymphoma. Participants should be suitable for the R-mini-CHOP treatment but specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-In
Participants receive R-mini-CHOP followed by AZD0486 to determine safety and tolerability
Phase III Treatment
Participants receive either R-mini-CHOP x2 followed by AZD0486 or R-mini-CHOP x6
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD0486
- R-mini-CHOP
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology