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

Indolent or Intermediate Grade B-cell Malignancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206777
• Other study ID #: OSU-10001
• Secondary ID: NCI-2012-00929
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2010
• Last updated: December 19, 2017
• Start date: October 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2017
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Indolent or Intermediate Grade B-cell Malignancy
• Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Grade III and IV Hypersensitivity Reactions		Every 15 minutes from start of infusion until completion, for up to 1 hour
Secondary	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
Secondary	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.	6 months, as a before and after infusion survey

External Links

•   Jamesline