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Combining AZD0486 with Rituximab for Untreated Follicular Lymphoma

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)

Phase 3 Interventional AstraZeneca · NCT06549595

This study is testing if a new treatment combining AZD0486 with rituximab can help people with untreated follicular lymphoma do better than the usual therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1018 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsrituximab
Locations159 sites (Anchorage, Alaska and 158 other locations)
Trial IDNCT06549595 on ClinicalTrials.gov

What this trial studies

This global, randomized, Phase III study evaluates the efficacy and safety of AZD0486 in combination with rituximab in patients with untreated follicular lymphoma. The study consists of a safety run-in to determine the recommended phase 3 dose (RP3D) of AZD0486, followed by a Phase III comparison of this combination against standard immunochemotherapy regimens chosen by investigators. Participants will be assigned to one of three treatment arms: two AZD0486 plus rituximab schedules or a comparator arm with standard regimens. The goal is to assess whether the new combination offers superior outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of follicular lymphoma Grades 1-3A and no prior systemic treatment.

Not a fit: Patients with Grade 3B follicular lymphoma or those with contraindications to the standard regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with untreated follicular lymphoma.

How similar studies have performed: Previous studies have shown promise in combining novel agents with established therapies for lymphoma, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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 Criteria:

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. History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to interfere with the evaluation of safety
5. Presence of \>5000 circulating lymphoma cells
6. Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment
7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

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

Where this trial is running

Anchorage, Alaska and 158 other locations

+109 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Untreated Follicular LymphomaFollicular Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.