AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Recruiting now · Phase 3

Conditions studied: Large B-cell Lymphoma

In brief

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.

Key facts

Study ID: NCT07215585
Run by: AstraZeneca
People needed: 420
Starts: 2025-11-11
Expected to finish: 2033-07-28
Last updated by the study team: 2026-06-18

Who can join

Age: 65 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 it is running

Research Site — Osaka, Japan (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Shanghai, China (enrolling)
Research Site — Kōtoku, Japan (enrolling)
Research Site — Yokohama, Japan (enrolling)
Research Site — Seoul, South Korea (enrolling)
Research Site — Jinan, China (enrolling)
Research Site — Leuven, Belgium (enrolling)
Research Site — Hong Kong, Hong Kong (enrolling)
Research Site — Bunkyō City, Japan (enrolling)
Research Site — Yamagata, Japan (enrolling)
Research Site — São Paulo, Brazil (enrolling)
Research Site — Calgary, Alberta, Canada (enrolling)
Research Site — Krakow, Poland (enrolling)
Research Site — Ghent, Belgium (enrolling)
Research Site — Ottawa, Ontario, Canada (enrolling)
Research Site — Beijing, China (enrolling)
Research Site — Changchun, China (enrolling)
Research Site — Chengdu, China (enrolling)
Research Site — Shanghai, China (enrolling)
Research Site — Yvoir, Belgium (enrolling)
Research Site — Guangzhou, China (enrolling)
Research Site — Porto Alegre, Brazil (enrolling)
Research Site — Melbourne, Australia (enrolling)
Research Site — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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