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Completed

NCT Number: NCT01206777

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

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.

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Key information

Conditions

Indolent or Intermediate Grade B-cell Malignancy Hypersensitivity Immune System Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 22, 2010
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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