RecruitingPhase 3NCT07215585

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

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)


Sponsor

AstraZeneca

Enrollment

420 participants

Start Date

Nov 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.


Eligibility

Min Age: 65 YearsMax Age: 130 Years

Inclusion Criteria14

  • 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.
  • 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

Interventions

DRUGAZD0486

Bispecific monoclonal IgG4 antibody

DRUGR-mini-CHOP

Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2


Locations(40)

Research Site

Melbourne, Australia

Research Site

Nedlands, Australia

Research Site

Antwerp, Belgium

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Brussels, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Roeselare, Belgium

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Yvoir, Belgium

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Porto Alegre, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Beijing, China

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Changchun, China

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Chengdu, China

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Guangzhou, China

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Jinan, China

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Nanchang, China

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Shanghai, China

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Shanghai, China

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Hong Kong, Hong Kong

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Lai Chi Kok, Hong Kong

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Shatin, Hong Kong

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Bunkyō City, Japan

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Kōtoku, Japan

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Osaka, Japan

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Sunto-gun, Japan

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Yamagata, Japan

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Yokohama, Japan

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Kielce, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Wroclaw, Poland

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Seoul, South Korea

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Seoul, South Korea

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Ankara, Turkey (Türkiye)

Research Site

Antalya, Turkey (Türkiye)

Research Site

London, United Kingdom

Research Site

Newcastle upon Tyne, United Kingdom

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