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

NCT ID: NCT01206777

Last Updated: 2017-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Indolent or Intermediate Grade B-cell Malignancy

Keywords

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Hypersensitivity Reactions B-cell malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rituximab

Group Type EXPERIMENTAL

Rituximab

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Jones, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26268782 (View on PubMed)

Related Links

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http://cancer.osu.edu

Jamesline

Other Identifiers

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NCI-2012-00929

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-10001

Identifier Type: -

Identifier Source: org_study_id