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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT01206777
Phase
PHASE2
Status
Completed

Conditions

  • Indolent or Intermediate Grade B-cell Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Dec 2017
Primary completion
Apr 30, 2013
Completion
Apr 30, 2013

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Incidence of Grade III and IV Hypersensitivity Reactions [ Time Frame: Every 15 minutes from start of infusion until completion, for up to 1 hour ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

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By research site
The Ohio State University Comprehensive Cancer Center· Columbus, OH