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

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Indolent or Intermediate Grade B-cell Malignancy

Treatments: Drug: Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01206777

OSU-10001

NCI-2012-00929 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Rituximab

Experimental group

Treatment:

Drug: Rituximab