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

This study is ongoing, but not recruiting participants.
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: August 28, 2013
Last verified: August 2013
  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:


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 ]

Enrollment: 51
Study Start Date: September 2010
Estimated Study Completion Date: May 2014
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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: August 28, 2013
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
Leukemia, Lymphocytic, Chronic, B-Cell
Hypersensitivity
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 01, 2014