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Looking for participantsPhase3

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL

Sponsor: AstraZeneca

NCT ID: NCT07215585

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0486 (drug), R-mini-CHOP (drug)
How long the study runs
Study runs about 92 months (dates as stated)
About the drug or intervention
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
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
65 Years to 130 Years
Who
All
Number of participants
420
Started
2025-11-11
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for large b-cell lymphoma
  • • Phase3 - 420 participants
  • • 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

Who can take part?

  • • Ages 65 Years to 130 Years
  • • Diagnosed with large b-cell lymphoma

Where?

  • • Glasgow, Scotland - Research Site
  • • London - Research Site
  • • Manchester - Research Site
  • • Newcastle upon Tyne - Research Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Large B-cell Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 65 Years - 130 Years
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

What the study is looking for

  • ✓confirmed by a biopsy diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma)...
  • ✓FDG-avid and cancer that can be measured on scans 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, kidney and heart function.
See the full 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.

Where Is This Study? (5 UK sites)

Research Site

Glasgow, Scotland G12 0YN, United Kingdom

WITHDRAWN

Research Site

London NW1 2PG, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

NOT_YET_RECRUITING

Research Site

Newcastle upon Tyne NE7 7AF, United Kingdom

Recruiting

Research Site

Nottingham NG5 1PB, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10