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

This study is currently recruiting participants.
Verified November 2012 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Jeffrey Jones, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01206777
First received: September 10, 2010
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  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: 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:

Drug Information available for: Rituximab
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Nursing satisfaction with rapid infusion protocol [ Time Frame: 6 months, as a before and after infusion survey ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206777

Contacts
Contact: Emily Dotson, Pharm.D. 614-366-0562 Emily.Dotson@osumc.edu

Locations
United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Emily Dotson         Emily.Dotson@osumc.edu    
Principal Investigator: Jeffrey Jones, MD            
Sponsors and Collaborators
Jeffrey Jones
Investigators
Principal Investigator: Jeffrey Jones, M.D., M.P.H. Ohio State University
  More Information

Additional Information:
Jamesline  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: September 10, 2010
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Hypersensitivity
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013