Clinical trial · Interventional
Feasibility Study of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-cell Malignancies
Assessment of Hypersensitivity Reactions and Feasibility of a 60 Minute Rapid Infusion Rituximab Protocol in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) at a Comprehensive Cancer Center
NCT01206777CI-TRIAL-00030866completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indolent or Intermediate Grade B-cell Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab
- interventionNames
- Drug: Rituximab
Primary outcomes (1)
- measure
- Incidence of Grade III and IV Hypersensitivity Reactions
- timeFrame
- Every 15 minutes from start of infusion until completion, for up to 1 hour
Secondary outcomes (2)
- measure
- Time Savings of a 60 Minute Infusion Versus Predicted Infusion Time Using Standard Second Dose Titration Schedule
- timeFrame
- Determined from difference in expected time by package insert administration and actual time on day of treatment
- measure
- Demonstrate Nursing Satisfaction for Administration of Rapid Infusion Over Standard Titration Practice
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDotson 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. PMID 26268782