AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
ConditionLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65-130
SponsorAstraZeneca
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
None
Trial design
Treatments tested in this trial
- AZD0486
- R-mini-CHOP
Treatment groups
420 Participants
are divided into 3 treatment groupsLocations
68Australia
Research Site3168, Clayton Australia
Research Site2109, Macquarie University Australia
Research Site3000, Melbourne Australia
Research Site6009, Nedlands Australia
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov