224
Participants
Start Date
July 31, 2024
Primary Completion Date
January 31, 2028
Study Completion Date
January 31, 2028
Obinutuzumab
"Participants will receive an intravenous infusion of 1,000mg Obinutuzumab at Weeks 0, 2, 24 and 26.~Prior to the administration of obinutuzumab, the participant will receive pre-medications consisting of all three:~* IV methylprednisolone 80 mg,~* Paracetamol 1,000 mg orally,~* Either cetirizine 10 mg orally or diphenhydramine 50 mg orally. These pre-medications must be completed between 30 to 60 minutes prior to the obinutuzumab infusion."
Oral prednisolone and cyclophosphamide
"Participants will receive a combination of oral prednisolone and cyclophosphamide with 2 options (Option A and B).~Option A: Cyclical prednisolone and cyclophosphamide with IV methylprednisolone~* IV methylprednisolone 500-1000 mg will be given on days 1, 2 and 3 at the start of months 1, 3, and 5.~* Oral prednisolone will be given at 0.5 mg/kg/day (max 50 mg/day) in months 1, 3, and 5.~* Oral cyclophosphamide will be given in months 2, 4 and 6, adjusted by age and weight~Option B: Concurrent prednisolone and cyclophosphamide without IV methylprednisolone~* Oral prednisolone will be given to meet a cumulative dose equivalent to 0.5 mg/kg/day for 90 days (max 50 mg/day).~* Oral cyclophosphamide will be given for 90 days, adjusted by age and weight"
Canberra Hospital, Garran
Royal Prince Alfred Hospital, Camperdown
Sunshine Coast University Hospital, Birtinya
Royal Brisbane and Women's Hospital, Brisbane
Bundaberg Hospital, Bundaberg
Cairns Hospital, Cairns
Logan Hospital, Logan City
Mackay Base Hospital, Mackay
Rockhampton Hospital, Rockhampton
Mater Hospital, South Brisbane
Princess Alexandra Hospital, Woolloongabba
Royal Hobart Hospital, Hobart
Fiona Stanley Hospital, Murdoch
University of Adelaide
OTHER
The University of Queensland
OTHER