Indolent or Intermediate Grade B-cell Malignancy
Conditions
Keywords
Hypersensitivity Reactions, B-cell malignancies
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.
Interventions
DRUGRituximab
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.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade III and IV Hypersensitivity Reactions | Every 15 minutes from start of infusion until completion, for up to 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule | Determined from difference in expected time by package insert administration and actual time on day of treatment | — |
| Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice | 6 months, as a before and after infusion survey | Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled from October 2010 to April 2013
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Rituximab: 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. | 52 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Rituximab |
|---|---|
| Age, Continuous | 63 years |
| Region of Enrollment United States | 52 patients |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Incidence of Grade III and IV Hypersensitivity Reactions
Time frame: Every 15 minutes from start of infusion until completion, for up to 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab | Incidence of Grade III and IV Hypersensitivity Reactions | 0 percentage of patients |
Secondary
Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice
Surveys were given to nurses in the outpatient infusion center to measure their satisfaction with the administration of the rapid infusion rate compared to standard titration practice.
Time frame: 6 months, as a before and after infusion survey
Population: Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab | Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice | 100 percentage of nurses satisfied |
Secondary
Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule
Time frame: Determined from difference in expected time by package insert administration and actual time on day of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Rituximab | Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule | 62.4 minutes for rapid R infusion |