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

Phase 2

Completed

• Conditions: Indolent or Intermediate Grade B-cell Malignancy
• Interventions: Drug: Rituximab

• Registration Number: NCT01206777
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Study Start: 2010-10
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-10-28
• Results First Submitted QC: 2015-02-05
• Results First Posted: 2015-02-23
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	6 months, as a before and after infusion survey	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.

Trial Locations

Locations (1)

The Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States