Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders

Conditions

• Hematologic Disorders
• Oncologic Disorders
• Rheumatologic Disorders

Eligibility Criteria

Sex

ALL

Age

1 Year - 19 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Giving rituximab as a rapid infusion over a period of 90 or 120 minutes.

Study Details

Rituximab is frequently used in adult and pediatric cancers, blood disorders, lymphoma (a cancerous growth made up of lymphoid tissue), graft-versus-host-disease (complication that can occur after a stem cell or bone marrow transplant), diseases of the immune system (the cells and substances that protect the body from infection) and rheumatologic conditions. Rituximab works by decreasing or temporarily eliminating a specific type of white blood cell, the B-lymphocyte. Overall, rituximab is generally well tolerated. The likelihood of an infusion-related reaction, or symptoms such as fever, chills, hives, low blood pressure or swelling, is very low, but highest during a patient's first infusion of rituximab and decreases with each additional dose. Adults commonly receive rituximab at a faster rate if they have done well with the first infusion, this study will help determine if the same approach is well tolerated in children. In this study, the investigators are testing a new method of administering rituximab which may reduce the time it takes to receive the medication. The initial ordered amount of rituximab will not change from the current standard of care (meaning what is usually done by doctors, and would likely be done if you were not on this study). The period of time over which rituximab is given is what is being studied.

Key Dates

Start date

Jun 30, 2015

Status verified

Jul 2018

Primary completion

Jan 31, 2017

Completion

Jan 31, 2017

Study Design

Enrollment

20 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rheumatologic disease
  Rituximab is administered over 120 minutes, 12.5% of the dose will be given over the first 30 minutes and the remaining 87.5% of the dose will be given over 90 minutes.
• Experimental: Cancer or blood disorder
  Rituximab is administered over 90 minutes, 20% of the dose will be given over the first 30 minutes and the remaining 80% of the dose will be given over 60 minutes.

Primary Outcome Measure

To determine the safety of rapid infusion rituximab in a pilot group of adolescent patients for hematologic, oncologic, and rheumatologic disorders. [ Time Frame: 6 weeks ]

Locations (1)

Find similar trials in Houston, TX

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