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RECRUITING
NCT07215585
PHASE3

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

65 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2025-11-11

Completion Date

2033-07-28

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DRUG

AZD0486

Bispecific monoclonal IgG4 antibody

DRUG

R-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 (45)

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Melbourne, Australia

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Nedlands, Australia

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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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Matsumoto-shi, Japan

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Meguro-ku, Japan

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Osaka, 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)

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Antalya, Turkey (Türkiye)

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Glasgow, Scotland, United Kingdom

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London, United Kingdom

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Newcastle upon Tyne, United Kingdom

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Nottingham, United Kingdom