Status:
COMPLETED
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Indolent or Intermediate Grade B-cell Malignancy
Eligibility:
All Genders
18-89 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01206777
Start Date
October 1 2010
End Date
April 1 2013
Last Update
December 20 2017
Active Locations (1)
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1
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210