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RecruitingLast updated: 25 September 2025

SOUNDTRACK-F1: This trial is recruiting people with untreated follicular lymphoma to evaluate combined targeted therapy compared to standard immunochemotherapyA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 130

Trial acronym

SOUNDTRACK-F1

Clinical summary

Summary

This study consists of 2 sequential parts:

  • Safety run in: will compare dose levels of the drug AZD0486 in combination with rituximab in order to establish the recommended phase 2 dose (RP3).
  • Phase III: will assess the superiority of AZD0486 at the RP3D in combination with rituximab, compared to the investigator's choice between three standard chemoimmunotherapy treatment regimens.

The Phase III part of the study consists of three treatment arms:

  • Arm A: treatment with AZD0486 plus rituximab Schedule A
  • Arm B: treatment with AZD0486 plus rituximab Schedule B
  • Arm C (comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance, or B-R + rituximab maintenance.

 

Conditions

This trial is treating people with previously untreated follicular lymphoma

Eligibility

Inclusion

  1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
  2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification
  3. ECOG performance status of 0 to 2
  4. No prior systemic lymphoma-directed therapy
  5. Need for systemic treatment meeting at least 1 GELF criteria
  6. FDG-avid and measurable disease
  7. Stage II to IV and FLIPI 2-5 [Phase III only]
  8. Adequate liver, hematological, renal and cardiac function.

The above is a summary, other inclusion criteria details may apply

Exclusion

  1. Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
  2. Contra-indication to BR, RCVP, and R-CHOP
  3. Participants with or history of CNS lymphoma
  4. Presence of >5000 circulating lymphoma cells
  5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific 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)

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