Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders

NCT02484053 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: H-35628 Rituximab
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematologic Disorders; Oncologic Disorders; Rheumatologic Disorders

Keywords

adult and pediatric cancers; blood disorders; lymphoma; graft-versus-host-disease; diseases of the immune system

Outcome Measures

Primary Outcomes (1)

• To determine the safety of rapid infusion rituximab in a pilot group of adolescent patients for hematologic, oncologic, and rheumatologic disorders.

  To be measured by the administration of rapid infusion rituximab without requiring modifications to therapy as a result of adverse reactions

  6 weeks

Secondary Outcomes (1)

• To determine the incidence of infusion-related reactions with the administration of rapid infusion rituximab

  6 weeks

Study Arms (2)

Rheumatologic disease

EXPERIMENTAL

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.

Drug: Rituximab

Cancer or blood disorder

EXPERIMENTAL

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.

Drug: Rituximab

Interventions

Rituximab DRUG

Giving rituximab as a rapid infusion over a period of 90 or 120 minutes.

Cancer or blood disorder; Rheumatologic disease

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic Diseases; Lymphoma; Graft vs Host Disease

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; 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

Study Officials

• Jenny Despotovic, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 29, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 11, 2018

Record last verified: 2018-07

Locations

US (1)