Rapid Rituximab Infusion at 90-minute Among Non-Hodgkin Lymphoma
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
Summary
This is an observational prospective cohort study design to evaluate the safety of rapid
Rituximab infusion at 90 minutes for Non-Hodgkin Lymphoma (NHL) patients. The secondary aim
is to measure the number of rejected chemotherapy administration on schedule. Non-Hodgkin
lymphoma patients who tolerated well for at least 2 cycles of standard infusion of Rituximab
without grade 3 or 4 adverse events will be recruited in the study. In this study, the first
20% of the total dose of rituximab will be administered over 30 minutes. When subjects
tolerate the infusion and stable vital signs, the remaining 80% of the total dose will be
administered over 60 minutes. Prior administration of Rituximab, premedication will be given
to the subjects including PO Paracetamol 1g, IV Diphenhydramine 25/50mg and/or IV
Hydrocortisone 100mg. The duration of subjects involvement in the study approximately takes
72 hours. Adverse events that occur within the first 24 hours of infusion will be evaluated
if related to Rituximab infusion as some subjects are receiving combination chemotherapy with
rituximab. This study will recruit both in patients and out-patients. A phone call to monitor
subject's health will be made post 24, 48, 72 hours of rituximab infusion. The findings from
this study will add evidence to the safety of rapid Rituximab infusion at 90 minutes. If the
outcome is favourable, NUH will consider adopting the new infusion rate for Rituximab
infusion for patients who tolerated at least 2 cycles of standard infusion recommended by the
drug manufacturer.
The study hypothesizes that rapid Rituximab infusion at 90 minutes is safe for NHL patients.