Overview

This trial is active, not recruiting.

Condition indolent or intermediate grade b-cell malignancy
Treatment rituximab
Phase phase 2
Target CD20
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
rituximab
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.

Primary Outcomes

Measure
Incidence of grade III and IV hypersensitivity reactions
time frame: Every 15 minutes from start of infusion until completion

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.