Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders

Completed · Early Phase 1

Conditions studied: Hematologic Disorders, Oncologic Disorders, Rheumatologic Disorders

In brief

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 facts

Study ID

NCT02484053

Run by

Baylor College of Medicine

People needed

20

Starts

2015-06-01

Expected to finish

2017-01-01

Last updated by the study team

2018-07-11

Who can join

Age: 1 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previously received and tolerated at least one rituximab infusion via standard infusion administration. *No modifications or adjustment to the infusion, or treatment with any anaphylaxis reaction medications required
• No history of Grades 3 or 4 infusion reaction to rituximab based on the NIH Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
• Prescribed rituximab with the following indications and doses for administration in the outpatient setting:
• Hematologic or oncologic indication: 100 mg/m\^2 or 375 mg/m\^2
• Rheumatologic indication: 375-750 mg/m\^2 (total dose not to exceed 1000 mg)

You may not qualify if…

• Any patient not meeting the inclusion criteria.
• Any patient who does not consent to the pilot protocol.
• Any patient on a clinical trial where the infusion rate of rituximab is prescribed by the clinical trial.
• Any patient who required rescue or symptomatic treatment with steroids, antihistamines, or epinephrine during prior rituximab infusions.
• Any patient who has received a bone marrow transplant.

Where it is running

• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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