Rapid Rituximab Infusion at 90-minute Among Non-Hodgkin Lymphoma
The recommended guideline for Rituximab infusion for first cycle is to be commencing at an
infusion rate of 50mg/hr for the first 30 minutes. If tolerated well, subsequent increments
will step up to 50mg/hr every 30 minutes to a maximum dose of 400mg/hr. For second and
subsequent infusions, the infusion rate commences at 100mg/hr with 30 minute increments of
100mg/hr to a maximum dose of 400mg/hr. The first and subsequent infusion generally
completes between 5-6 and 3-4 hours respectively.
Lengthy infusions translate into higher costs and longer waiting times for patients due to
scant resources. Therefore, there is growing interest globally in shortening the overall
infusion times to either 90 or 60-minutes. A recent systematic review evaluating safety of
rapid Rituximab infusion has confirmed that Rituximab at 90-minutes is safe for NHL
patients. However 60-minute infusion was not recommended for neither NHL nor chronic
lymphocytic leukemia (CLL) patients due to lack of evidence.
Although the rapid Rituximab infusion at 90-minute has been tested among Singapore
population in National Cancer Centre, it was not being evaluated among the cohort of
patients who received treatment in National University Hospital Singapore. As rapid
Rituximab infusion remain off label use, this research study intend to evaluate the safety
of rapid Rituximab infusion at 90-minute among NHL patients.
The selected doses will be 375mg/m2 as recommended and approved by FDA.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of rapid Rituximab infusion at 90-minute for NHL
This is an observational prospective cohort study design with single group. The duration of subjects involvement in the study is approximately 72 hours. Adverse events that will occur within 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-patient. A phone call to monitor subject's health will be made post 24, 48 and 72 hours of rituximab infusion.
Chng Wee Joo, MBBS
National University Hospital, Singapore
Singapore: Domain Specific Review Boards
DSRB Ref. 2011/02052