AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
NCT ID: NCT07215585
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
420 participants
INTERVENTIONAL
2025-11-11
2033-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase III Arm A: R-mini-CHOP and AZD0486
2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D.
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
Phase III Arm B: R-mini-CHOP
6 cycles of R-mini-CHOP per SoC regimen.
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
Safety Run in: R-mini-CHOP and AZD0486
2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
65 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Dickinson,, MBBS BS DMSc
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Center
Locations
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Research Site
Melbourne, , Australia
Research Site
Nedlands, , Australia
Research Site
Antwerp, , Belgium
Research Site
Brussels, , Belgium
Research Site
Ghent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Roeselare, , Belgium
Research Site
Yvoir, , Belgium
Research Site
Porto Alegre, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Chengdu, , China
Research Site
Guangzhou, , China
Research Site
Nanchang, , China
Research Site
Shandong, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Hong Kong, , Hong Kong
Research Site
Lai Chi Kok, , Hong Kong
Research Site
Shatin, , Hong Kong
Research Site
Bunkyō City, , Japan
Research Site
Kōtoku, , Japan
Research Site
Osaka, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Yamagata, , Japan
Research Site
Yokohama, , Japan
Research Site
Kielce, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Wroclaw, , Poland
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Antalya, , Turkey (Türkiye)
Research Site
London, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2025-522029-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7402C00001
Identifier Type: -
Identifier Source: org_study_id
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