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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Treatments: Rituximab

Criteria

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