AZD0486 with short-course R-mini-CHOP for older or unfit people with large B‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional comparison studies a shorter chemotherapy course (R-mini-CHOP × 2) followed by the investigational agent AZD0486 versus the standard six cycles of R-mini-CHOP in newly diagnosed large B‑cell lymphoma. Eligible participants are older adults (≥80 years) or people aged 65–79 judged unfit for full‑dose R‑CHOP, with FDG‑avid, measurable disease from stage I bulky to stage IV and ECOG performance status 0–2. The trial tracks response by imaging and clinical criteria and monitors safety and tolerability over follow‑up. The aim is to see if adding AZD0486 after abbreviated chemo can preserve disease control while improving tolerability in a population who cannot receive full‑dose therapy.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Melbourne, Australia Recruiting
• Research Site
  Ghent, Belgium Recruiting
• Research Site
  Leuven, Belgium Recruiting
• Research Site
  Yvoir, Belgium Recruiting
• Research Site
  Porto Alegre, Brazil Recruiting
• Research Site
  São Paulo, Brazil Recruiting

+32 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Michael Dickinson,, MBBS BS DMSc — Peter MacCallum Cancer Center
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.