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

NCT01206777 | Completed Phase 2 Results DMC

• 2 other identifiers: OSU-10001NCI-2012-00929
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Indolent or Intermediate Grade B-cell Malignancy

Keywords

Hypersensitivity Reactions; B-cell malignancies

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade III and IV Hypersensitivity Reactions

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

Secondary Outcomes (2)

• 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

Study Arms (1)

Rituximab

EXPERIMENTAL

Drug: Rituximab

Interventions

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.

Rituximab

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 26268782 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Hypersensitivity

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Jeffrey Jones, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Jeffrey.Jones@osumc.edu

614-688-7942

Study Officials

• Jeffrey Jones, M.D., M.P.H.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 20, 2017
• Results First Posted: February 23, 2015

Record last verified: 2017-12

Locations

US (1)