Trial Outcomes & Findings for Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies (NCT NCT01206777)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Every 15 minutes from start of infusion until completion, for up to 1 hour

Results posted on

2017-12-20

Participant Flow

Patients were enrolled from October 2010 to April 2013

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	52
Overall Study Discontinued Trial and Deemed Ineligible	2
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=52 Participants 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.
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	31 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Region of Enrollment United States	52 patients n=93 Participants

PRIMARY outcome

Timeframe: Every 15 minutes from start of infusion until completion, for up to 1 hour

Outcome measures

Outcome measures
Measure	Rituximab n=50 Participants 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.
Incidence of Grade III and IV Hypersensitivity Reactions	0 percentage of patients

SECONDARY outcome

Timeframe: Determined from difference in expected time by package insert administration and actual time on day of treatment

Outcome measures

Outcome measures
Measure	Rituximab n=50 Participants 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.
Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule	62.4 minutes for rapid R infusion Interval 61.2 to 63.6

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Rituximab n=50 Participants 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.
Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice	100 percentage of nurses satisfied

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Jones, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-688-7942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place