Recruiting NCT07215585

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Phase III Interventional Large B-cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AZD0486, R-mini-CHOP.
Who it may be relevant to: Registry conditions: Large B-cell Lymphoma. Basic parameters: 65 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Australia, Belgium, Brazil, Canada, China +6
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

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

Primary outcome measures

SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Time frame: Up to 1 year]
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Time frame: Up to 1 year]
SRI - Determination of the recommended Phase III dose (RP3D) [Time frame: Up to 1 year]
Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen. [Time frame: Up to 7 years]

Secondary outcome measures (12)

Safety Run-In and Phase 3 - ORR [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - CR Rate [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - DoR [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - DoCR [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - PFS [Time frame: Up to 7 years]
Safety Run In and Phase 3 - OS [Time frame: Up to 7 years]
Phase 3 - Time from randomisation to second progression or death (PFS2) [Time frame: Up to 7 years]
Phase 3 - Time to First Subsequent Therapy or Death (TFST) [Time frame: Up to 7 Years]
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Time frame: Up to 7 years]
Phase 3 - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: serum concentration of study drug [Time frame: Up to 7 years]
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Maximum plasma concentration of the study drug (Cmax). [Time frame: Up to 7 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment

Study locations

China · 18 centers

Research Site — Beijing
Research Site — Changchun
Research Site — Chengdu
Research Site — Chongqing
Research Site — Fuzhou
Research Site — Guangzhou
Research Site — Guangzhou
Research Site — Haikou
… and 10 more centers

Japan · 17 centers

Research Site — Akashi
Research Site — Bunkyō City
Research Site — Himeji-shi
Research Site — Kōtoku
Research Site — Kumamoto
Research Site — Matsumoto-shi
Research Site — Matsuyama
Research Site — Meguro-ku
… and 9 more centers

Belgium · 6 centers

Research Site — Antwerp
Research Site — Brussels
Research Site — Ghent
Research Site — Leuven
Research Site — Roeselare
Research Site — Yvoir

Australia · 5 centers

Research Site — Clayton
Research Site — Macquarie University
Research Site — Melbourne
Research Site — Nedlands
Research Site — Waratah

Poland · 5 centers

Research Site — Kielce
Research Site — Krakow
Research Site — Lodz
Research Site — Lublin
Research Site — Wroclaw

Canada · 4 centers

Research Site — Calgary
Research Site — Victoria
Research Site — Hamilton
Research Site — Ottawa

United Kingdom · 4 centers

Research Site — Glasgow, Scotland
Research Site — London
Research Site — Newcastle upon Tyne
Research Site — Nottingham

Hong Kong · 3 centers

Research Site — Hong Kong
Research Site — Lai Chi Kok
Research Site — Shatin

Brazil · 2 centers

Research Site — Porto Alegre
Research Site — São Paulo

South Korea · 2 centers

Research Site — Seoul
Research Site — Seoul

Turkey (Türkiye) · 2 centers

Research Site — Ankara
Research Site — Antalya

Identifiers

NCT: NCT07215585 · D7402C00001 · 2025-522029-37-00

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗