AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

NCT07215585 · tracked via the Priya Life Science UK tracker

Sponsor

AstraZeneca

Phase

Phase 3

Started

2025-11-11

Last updated

2026-06-18

Condition(s) studied

Large B-cell Lymphoma

Investigational drug(s) / intervention(s)

AZD0486R-mini-CHOP

AZD0486: Bispecific monoclonal IgG4 antibody

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

Study 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

Sex

ALL

Min age

65 Years

Max age

130 Years

Healthy volunteers

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.

Primary outcome measure(s)

SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. — Up to 1 year
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. — Up to 1 year
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
SRI - Determination of the recommended Phase III dose (RP3D) — Up to 1 year
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen. — Up to 7 years
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.

Trial sites (68)

Facility	City	Region	Status
Research Site	Clayton	Australia	Not Yet Recruiting
Research Site	Macquarie University	Australia	Withdrawn
Research Site	Melbourne	Australia	Recruiting
Research Site	Nedlands	Australia	Not Yet Recruiting
Research Site	Waratah	Australia	Not Yet Recruiting
Research Site	Antwerp	Belgium	Withdrawn
Research Site	Brussels	Belgium	Not Yet Recruiting
Research Site	Ghent	Belgium	Recruiting
Research Site	Leuven	Belgium	Recruiting
Research Site	Roeselare	Belgium	Suspended
Research Site	Yvoir	Belgium	Recruiting
Research Site	Porto Alegre	Brazil	Recruiting
Research Site	São Paulo	Brazil	Recruiting
Research Site	Calgary	Alberta	Recruiting
Research Site	Victoria	British Columbia	Not Yet Recruiting
Research Site	Hamilton	Ontario	Not Yet Recruiting
Research Site	Ottawa	Ontario	Recruiting
Research Site	Beijing	China	Recruiting
Research Site	Changchun	China	Recruiting
Research Site	Chengdu	China	Recruiting
Research Site	Chongqing	China	Not Yet Recruiting
Research Site	Fuzhou	China	Not Yet Recruiting
Research Site	Guangzhou	China	Recruiting
Research Site	Guangzhou	China	Not Yet Recruiting
Research Site	Haikou	China	Not Yet Recruiting
Research Site	Hefei	China	Not Yet Recruiting
Research Site	Jinan	China	Recruiting
Research Site	Kunming	China	Not Yet Recruiting
Research Site	Nanchang	China	Not Yet Recruiting
Research Site	Nanning	China	Not Yet Recruiting
Research Site	Nantong	China	Withdrawn
Research Site	Shanghai	China	Recruiting
Research Site	Shanghai	China	Recruiting
Research Site	Wuhan	China	Not Yet Recruiting
Research Site	Xiamen	China	Not Yet Recruiting
Research Site	Hong Kong	Hong Kong	Recruiting
Research Site	Lai Chi Kok	Hong Kong	Not Yet Recruiting
Research Site	Shatin	Hong Kong	Withdrawn
Research Site	Akashi	Japan	Not Yet Recruiting
Research Site	Bunkyō City	Japan	Recruiting

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215585 on ClinicalTrials.gov ↗ ← All trials in the UK