Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
This trial is active, not recruiting.
|Condition||indolent or intermediate grade b-cell malignancy|
|Sponsor||Ohio State University Comprehensive Cancer Center|
|Start date||September 2010|
|End date||April 2013|
|Trial size||51 participants|
|Trial identifier||NCT01206777, NCI-2012-00929, OSU-10001|
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.
|Intervention model||single group assignment|
Incidence of grade III and IV hypersensitivity reactions
time frame: Every 15 minutes from start of infusion until completion
Time savings of a 60 minute infusion versus predicted infusion time using standard second dose titration schedule
time frame: Determined from difference in expected time by package insert administration and actual time on day of treatment
Nursing satisfaction with rapid infusion protocol
time frame: 6 months, as a before and after infusion survey
Male or female participants from 18 years up to 89 years old.
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
|Official title||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|
|Principal investigator||Jeffrey Jones, M.D., M.P.H.|
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