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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01482754
First received: November 28, 2011
Last updated: December 8, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Non Hodgkin Lymphoma
Drug: Rituximab (Mabthera®, Roche Pty Ltd, Basel, Switzerland)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Rituximab Infusion at 90-minute Among Non-Hodgkin Lymphoma

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Safety of rapid Rituximab infusion at 90-minute for NHL [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • number of rejected chemotherapy administration on schedule. [ Time Frame: 5-6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab Infusion at 90-minutes Drug: Rituximab (Mabthera®, Roche Pty Ltd, Basel, Switzerland)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482754

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Chng Wee Joo, MBBS National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Haematology-Oncology, Prof. Chng Wee Joo, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01482754     History of Changes
Other Study ID Numbers: DSRB Ref. 2011/02052
Study First Received: November 28, 2011
Last Updated: December 8, 2013
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014