AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Sponsor
AstraZeneca
Study ID
NCT07215585
Phase
PHASE3
Status
Recruiting
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Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0486 — DRUG
    Bispecific monoclonal IgG4 antibody
  • R-mini-CHOP — DRUG
    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 Details

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 Dates

First listed
Oct 10, 2025
Start date
Nov 11, 2025
Status verified
Jun 2026
Primary completion
Jun 10, 2030
Completion
Jul 28, 2033

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase III Arm A: R-mini-CHOP and AZD0486
    2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D.
  • Active Comparator: Phase III Arm B: R-mini-CHOP
    6 cycles of R-mini-CHOP per SoC regimen.
  • Experimental: Safety Run in: R-mini-CHOP and AZD0486
    2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D.

Primary Outcome Measure

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 ]

Central Contacts

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