Rapid Rituximab Infusion at 90-minute Among Non-Hodgkin Lymphoma

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• The diagnosis of NHL is confirmed through histology report.

• Adult with age 21 years old and above

• Tolerated first and second cycles or at least two cycles of Rituximab infusion at recommended rate without Grade 3 or 4 adverse event during infusion

• Presence of any co-morbidity

• Ability to provide informed consent

Exclusion Criteria:

Subjects who diagnosed with NHL with high lymphocytes counts will be excluded from the study.