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

This study has been completed.
Information provided by (Responsible Party):
Jeffrey Jones, Ohio State University Comprehensive Cancer Center Identifier:
First received: September 10, 2010
Last updated: February 26, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Indolent or Intermediate Grade B-cell Malignancy
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 [ Time Frame: 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.

Enrollment: 52
Study Start Date: October 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab 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.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01206777

United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Principal Investigator: Jeffrey Jones, M.D., M.P.H. Ohio State University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeffrey Jones, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT01206777     History of Changes
Other Study ID Numbers: OSU-10001
NCI-2012-00929 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
Study First Received: September 10, 2010
Results First Received: October 28, 2014
Last Updated: February 26, 2015

Keywords provided by Ohio State University Comprehensive Cancer Center:
Hypersensitivity Reactions
B-cell malignancies

Additional relevant MeSH terms:
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 23, 2017