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

Phase 2CompletedNCT01206777

Ohio State University Comprehensive Cancer Center52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Indolent or Intermediate Grade B-cell Malignancy

Interventions

RituximabDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Incidence of Grade III and IV Hypersensitivity Reactions

Time frame: Every 15 minutes from start of infusion until completion, for up to 1 hour

Secondary Outcomes

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

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.

Time frame: 6 months, as a before and after infusion survey

Data from ClinicalTrials.gov

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