臨床研究等提出・公開システム

A Phase III, Multicentre, Open-label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x 2 followed by AZD0486 versus R-mini-CHOP x 6 in Elderly or Unfit Participants with Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)

AZD0486 1L Therapy for Elderly or Unfit Participants with LBCL

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Hibi Kazushige

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3600

RD-clinical-information-Japan@astrazeneca.com

Recruiting

Jan. 05, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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 ly
mphoma) 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

Both

Large B-cell Lymphoma

Drug: AZD0486
Drug: R-mini-CHOP

Safety Run-in part: AEs, SAEs, AESI, events of clinical interest, AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.

Phase III part: PFS (the time from date of randomisation until disease progression as per Lugano 2014 as assessed by BICR, or death due to any cause.)

+81-3-3823-2101

Nov. 25, 2025

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Austria/India/Australia/Italy/Belgium/Brazil/Norway/Canada/Poland /China/South Korea/Denmark/Spain/Finland/Sweden/France/Switzerland/Germany/Turkey/Hong Kong/UK/Hungary/USA