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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00929 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade III and IV Hypersensitivity Reactions | Every 15 minutes from start of infusion until completion, for up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Jones, M.D., M.P.H. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26268782 | Derived | Dotson E, Crawford B, Phillips G, Jones J. Sixty-minute infusion rituximab protocol allows for safe and efficient workflow. Support Care Cancer. 2016 Mar;24(3):1125-9. doi: 10.1007/s00520-015-2869-4. Epub 2015 Aug 14. |
| Label | URL |
|---|---|
| Jamesline | View source |
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Patients were enrolled from October 2010 to April 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Grade III and IV Hypersensitivity Reactions | Posted | Number | percentage of patients | Every 15 minutes from start of infusion until completion, for up to 1 hour |
|
|
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The study utilized the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 for adverse event reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Jones, MD | The Ohio State University Comprehensive Cancer Center | 614-688-7942 | Jeffrey.Jones@osumc.edu |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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. |
| 6 months, as a before and after infusion survey |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | patients |
|
|
| Secondary | Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule | Posted | Mean | 95% Confidence Interval | minutes for rapid R infusion | Determined from difference in expected time by package insert administration and actual time on day of treatment |
|
|
|
| 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. | Post infusion surveys were collected and de-identified by assignment of an individual nurse identification number | Posted | Number | percentage of nurses satisfied | 6 months, as a before and after infusion survey |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
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| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |