Phase 2
Completed N=52
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Indolent or Intermediate Grade B-cell Malignancy
Source: ClinicalTrials.gov NCT01206777 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Incidence of Grade III and IV Hypersensitivity Reactions — 0 percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade III and IV Hypersensitivity Reactions |
— | — |
| SECONDARY Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule |
62.4 | — |
| SECONDARY Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice |
100 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01206777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.