39
Participants
Start Date
December 11, 2023
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2031
Epcoritamab
"Epcoritamab (Epcor) is a bispecific antibody recognizing the T-cell antigen CD3 and the B-cell antigen CD20. Epcor is a supplied as a concentrate for solution for intended subcutaneous injection. The dose must be prepared by a qualified pharmacist using aseptic technique.~Epcoritamab-Salvage treatment phase:~2-3 cycles of R-DHAOx therapy (rituximab, dexamethasone, cytarabine, oxaliplatin), given every 21 days combined with Epcoritamab subcutaneous weekly dosing (priming 0.16mg Cycle 1 Day 1, intermediate 0.8mg cycle 1 day 8, full dose 48mg from cycle 1 day 15 onwards)~Epcoritamab Consolidation phase:~6 cycles (28 days each) of subcutaneous Epcoritamab, commencing between 6-12 weeks post ASCT.~Epcoritamab dosing and timing for consolidation:~* Cycle 1 Day 1: Priming (0.16mg) dose~* Cycle 1 Day 8: intermediate (0.8mg) dose~* Cycle 1 Day 15: full dose 48mg~* Cycle 1 Day 22, Cycle 2-3 Days 1, 8, 15 and 22: 48mg~* Cycles 4 to 6 - Days 1 and 15 (fortnightly dosing): 48mg"
RECRUITING
Australasian Leukemia and Lymphoma Group, Melbourne
Australasian Leukaemia and Lymphoma Group
OTHER