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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206777
First Posted: September 22, 2010
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey Jones, Ohio State University Comprehensive Cancer Center
  Purpose
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: None (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 Jeffrey Jones, 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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206777


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Jones, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01206777     History of Changes
Other Study ID Numbers: OSU-10001
NCI-2012-00929 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Submitted: September 10, 2010
First Posted: September 22, 2010
Results First Submitted: October 28, 2014
Results First Posted: February 23, 2015
Last Update Posted: March 17, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Neoplasms
Hypersensitivity
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents