AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
NCT07215585 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420
Last updated 2026-05-22
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.
Conditions
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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Michael Dickinson,, MBBS BS DMSc · Peter MacCallum Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-11
- Primary Completion
- 2030-06-10
- Completion
- 2033-07-28
- FDA Drug
- Yes
Countries
- Australia
- Belgium
- Brazil
- Canada
- China
- Hong Kong
- Japan
- Poland
- South Korea
- Turkey (Türkiye)
- United Kingdom
Study Locations
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