Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility of a 60 minute rapid infusion rituximab protocol in the institution's outpatient infusion center.

Official Title
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Assessment of Hypersensitivity Reactions and Feasibility of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) at a Comprehensive Cancer Center

Conditions
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Indolent or Intermediate Grade B-cell Malignancy

Intervention / Treatment
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* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-89 Diagnosis of indolent or intermediate grade B-cell malignancy Patients receiving rituximab-based therapy at a dose of 375mg/m2, regardless of weight First dose given within 3 months of the second dose Infusion scheduled for outpatient administration at The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute Exclusion Criteria: Diagnosis of aggressive lymphoma Absolute lymphocyte count > 10 x 103 cells/µL New York Heart Association (NYHA) classification Grade II or greater congestive heart failure Enrolled on another clinical trial Allergy to murine-containing medications Grade III or IV hypersensitivity reaction during the initial infusion of rituximab Prisoners Pregnant women Mentally or physically unable to give consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br> | Drug: Rituximab<br>* Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Grade III and IV Hypersensitivity Reactions |  | Every 15 minutes from start of infusion until completion, for up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule |  | Determined from difference in expected time by package insert administration and actual time on day of treatment | 
| Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice | Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice. | 6 months, as a before and after infusion survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypersensitivity Reactions, B-cell malignancies