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AZD0486 with short-course R-mini-CHOP for older or unfit people with large B‑cell lymphoma

A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)

Phase 3 Interventional AstraZeneca · NCT07215585

This tests whether two cycles of R-mini-CHOP followed by AZD0486 work as well and cause fewer side effects than six cycles of R-mini-CHOP for people aged 80+ or 65–79 who are unfit with newly diagnosed large B‑cell lymphoma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment420 (estimated)
Ages65 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations62 sites (Melbourne and 61 other locations)
Trial IDNCT07215585 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional comparison studies a shorter chemotherapy course (R-mini-CHOP × 2) followed by the investigational agent AZD0486 versus the standard six cycles of R-mini-CHOP in newly diagnosed large B‑cell lymphoma. Eligible participants are older adults (≥80 years) or people aged 65–79 judged unfit for full‑dose R‑CHOP, with FDG‑avid, measurable disease from stage I bulky to stage IV and ECOG performance status 0–2. The trial tracks response by imaging and clinical criteria and monitors safety and tolerability over follow‑up. The aim is to see if adding AZD0486 after abbreviated chemo can preserve disease control while improving tolerability in a population who cannot receive full‑dose therapy.

Who should consider this trial

Good fit: Ideal candidates are people with newly diagnosed, FDG‑avid and measurable large B‑cell lymphoma who are ≥80 years old or 65–79 and judged unfit for full‑dose R‑CHOP, with ECOG 0–2 and adequate organ function.

Not a fit: Patients who are younger and fit for full‑dose R‑CHOP, those with excluded lymphoma subtypes (for example plasmablastic lymphoma or post‑transplant lymphoproliferative disease), or those with inadequate organ function are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could maintain cancer control while reducing chemotherapy exposure and side effects for older or frail patients.

How similar studies have performed: Other CD3xCD19 bispecific therapies have shown promising activity in large B‑cell lymphoma, but using such agents after abbreviated frontline chemo in this population is novel and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
* Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
* FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
* Stage I bulky (7.5 cm and greater) to Stage IV;
* ECOG performance status 0 to 2;
* Adequate bone marrow, liver, renal and cardiac function.

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

* As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
* Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
* History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
* Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
* Active or uncontrolled infection
* Major cardiac abnormalities
* Prior anti-lymphoma therapy except for corticosteroids for symptom control
* Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions

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

Where this trial is running

Melbourne and 61 other locations

+12 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 Large B-cell LymphomaLBCLAZD0486CD3CD19TCEB-cell malignanciesSoundtrack-D2
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.