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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


Phase 2
18 Years
89 Years
Open (Enrolling)
Both
Indolent or Intermediate Grade B-cell Malignancy

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of grade III and IV hypersensitivity reactions

Outcome Time Frame:

Every 15 minutes from start of infusion until completion

Safety Issue:

Yes

Principal Investigator

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

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-10001

NCT ID:

NCT01206777

Start Date:

September 2010

Completion Date:

February 2013

Related Keywords:

  • Indolent or Intermediate Grade B-cell Malignancy
  • Hypersensitivity Reactions
  • B-cell malignancies
  • Neoplasms
  • Hypersensitivity
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
The Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210