CompletedPhase 2

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

United States52 participantsStarted 2010-10

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of Grade III and IV Hypersensitivity Reactions

Timeframe: Every 15 minutes from start of infusion until completion, for up to 1 hour

Trial details

NCT IDNCT01206777

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2014-10-28

View on ClinicalTrials.gov More Indolent or Intermediate Grade B-cell Malignancy trials