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

Sponsor
National University Hospital, Singapore
Study ID
NCT01482754
Status
Completed

Conditions

  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab (Mabthera®, Roche Pty Ltd, Basel, Switzerland) — DRUG
    Recommended and approved dosage of Rituximab is 375mg/m2. The recommended guideline for Rituximab infusion for first cycle is commencing at an infusion rate of 50mg/hr for the first 30 minutes. If tolerated well, the 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.

Study Details

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.

Key Dates

Start date
May 31, 2012
Status verified
Dec 2013
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Infusion at 90-minutes

Primary Outcome Measure

Safety of rapid Rituximab infusion at 90-minute for NHL [ Time Frame: 72 hours ]

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