Hematologic DisordersEarly Phase 1NCT02484053
Rapid Infusion Rituximab, Hematologic, Oncologic, and Rheumatologic Disorders
A Early Phase 1 study testing Rituximab in people with Hematologic Disorders and Oncologic Disorders, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- Hematologic Disorders, Oncologic Disorders, Rheumatologic Disorders
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Rapid Infusion Rituximab in a Pilot Group of Adolescents With Hematologic, Oncologic, and Rheumatologic Disorders
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.
Read the 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).
- Being tested
- Rituximab
- Keywords
- adult and pediatric cancers, blood disorders, lymphoma, graft-versus-host-disease, diseases of the immune system
- Medical subject headings
- Hematologic Diseases, Lymphoma, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Giving rituximab as a rapid infusion over a period of 90 or 120 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
To determine the incidence of infusion-related reactions with the administration of rapid infusion rituximab
To be measured as the number of patients who experience a grade 3 or higher infusion-related reaction
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DisordersStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Despotovic, Baylor College of Medicine
- Investigators
- Jenny Despotovic, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484053
- Sponsor's protocol ID
- H-35628 Rituximab
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2015
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Rapid Infusion Rituximab in a Pilot Group of Adolescents With Hematologic, Oncologic, and Rheumatologic Disorders
- ClinicalTrials.gov ID
- NCT02484053
- Acronym / sponsor ID
- H-35628 Rituximab
- Keywords
- adult and pediatric cancers, blood disorders, lymphoma, graft-versus-host-disease, diseases of the immune system
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatologic disease | Experimental | Drug: RituximabRituximab 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. |
| Cancer or blood disorder | Experimental | Drug: RituximabRituximab 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. |
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabGiving rituximab as a rapid infusion over a period of 90 or 120 minutes. | Drug | Cancer or blood disorder, Rheumatologic disease |
Primary outcome
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
To be measured by the administration of rapid infusion rituximab without requiring modifications to therapy as a result of adverse reactions
1 secondary outcome
To determine the incidence of infusion-related reactions with the administration of rapid infusion rituximab
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Despotovic, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rituximab in people with Hematologic Disorders and Oncologic Disorders, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.