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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AZD0486
DrugBispecific monoclonal IgG4 antibody
R-mini-CHOP
DrugIntravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2
Treatment groups
420 Participants
are divided into 3 treatment groupsGroup A: Phase III Arm A: R-mini-CHOP and AZD0486Experimental treatment 2 interventions
Group B: Phase III Arm B: R-mini-CHOPActive comparator 1 intervention
Group C: Safety Run in: R-mini-CHOP and AZD0486Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Time frame
Up to 1 year2
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Time frame
Up to 1 year3
SRI - Determination of the recommended Phase III dose (RP3D)
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
Time frame
Up to 1 year4
Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen.
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.
Time frame
Up to 7 yearsSecondary outcomes
1
Safety Run-In and Phase 3 - ORR
ORR defined as the proportion of participants achieving either a PR or CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
Time frame
Up to 7 years2
Safety Run-In and Phase 3 - CR Rate
CR rate is defined as the proportion of participants achieving a CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
Time frame
Up to 7 years3
Safety Run-In and Phase 3 - DoR
DoR is defined as the time from the date of first documented response until the date of documented progression based on Lugano 2014 criteria as determined by Investigator assessment or death due to any cause.
Time frame
Up to 7 years4
Safety Run-In and Phase 3 - DoCR
DoCR is defined as the time from the date of first documented CR until the date of documented progression or death due to any cause, as assessed by the Investigator.
Time frame
Up to 7 yearsSponsors and contacts
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Source ClinicalTrials.gov