Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders
Condition: Hematologic Disorders; Oncologic Disorders; Rheumatologic Disorders
MeSH terms: Rheumatic Diseases; Hematologic Diseases; Collagen Diseases
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      The standard of care in patients receiving rituximab is to give the dose slowly and gradually
      increase the rate of rituximab until the full dose is given, which may take several hours.
      This is done in order to prevent a side effect of rituximab called an infusion reaction.
      Infusion reactions are similar to allergic reactions and may cause symptoms such as low blood
      pressure, wheezing, chest tightness, fever, itching, bad cough, blue skin color, seizures, or
      swelling of the face, lips, tongue, or throat.

      In this study, the investigators are testing the method of giving rituximab over a shorter
      period of time. Administering rituximab at this faster rate is done commonly and safely in
      the adult population with very few side effects.

      The drug rituximab will be given as an infusion in the outpatient clinic. Infusion means the
      drug is given using a needle or tubing inserted into a vein (also called an IV) over a period
      of time.

      If patients have a cancer or blood disorder, they will receive rituximab administration 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. This is the standard method of infusing doses of
      rituximab in adults who have a cancer or blood disorder, and have done well with a first dose
      of rituximab at the standard infusion rate.

      If patients have a rheumatologic disease, they will receive rituximab administration 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. This is the standard method of infusing doses of
      rituximab in adults who have a rheumatologic disorder, and have done well with a first dose
      of rituximab at the standard infusion rate.

      During this time, the investigator will also assess to see if patients have any side effects
      from receiving the faster infusion and for 15 minutes following the end of the infusion.
      Patients will also be followed up by phone or in clinic one week after the rapid infusion of
      rituximab to see if they have any side effects.

      Before patients receive rituximab, they will receive acetaminophen and diphenhydramine. These
      medications are given to help prevent an infusion reaction from occurring. These medications
      are always given no matter how quickly rituximab is given.

      If an infusion reaction occurs, the rituximab infusion will stop and patients will receive
      medications to help reverse the reaction. Once the reaction has gone away, the patient's
      doctor will determine if and how they will receive the rest of their rituximab dose.

      Patients will receive one rapid infusion of rituximab as part of their participation in this
      study. If patients did not have an infusion-related reaction they are eligible to receive
      subsequent infusions off protocol at the discretion of the provider.

      Patients will be asked to allow us to view and collect information from their medical records
      prior to their infusion to ensure eligibility and obtain baseline data, as needed on the day
      of their infusion and through the next clinical follow up to monitor for side effects from
      the infusion. Data collected from the medical records includes but is not limited to,
      demographic information (age, race/ethnicity, weight, diagnoses, and indication for
      rituximab).
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Giving rituximab as a rapid infusion over a period of 90 or 120 minutes.
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult and pediatric cancers; blood disorders; lymphoma; graft-versus-host-disease; diseases of the immune system