Large B-cell LymphomaNCT04503538
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
A study testing Telemedicine visit in people with Large B-cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Wake Forest University Health Sciences.
Trial summary
The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma
- What is being tested?
- Telemedicine visit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Nov 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma
- Age ≥ 18 years
- ECOG or Karnofsky performance status of ≤ 2
- Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion
- Patients must stay within a 30-minute distance from the cancer center
- Patients must have access to wifi network or a cellular network
- Patients and caregiver(s) participating in patient's care must attend the education session for outpatient CAR-T and demonstrate competency to collect vital signs with equipment provided
- Must have the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Who cannot join
- Patients who have acute lymphoblastic leukemia/lymphoma
- Patients who have a high tumor burden (> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient
- Patient or caregiver unable to understand and follow English language
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
About this study
Official title: Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.
Read the detailed description
Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient)
Secondary Objective(s)
- To determine how many times a telemedicine visit triggered an action (inpatient admission/ outpatient observation status)
- To determine how many patients were detected to have cytokine release syndrome and/or neurotoxicity based on their telemedicine visit
- Conditions
- Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
- Being tested
- Telemedicine visit
- Keywords
- Relapsed large B-cell lymphoma, Refractory large B-cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine visitOther
Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cell therapy and Telemedicine | Other | All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours) Receives: Other: Telemedicine visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Successfully Completed Telemedicine Visits
To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.
Measured: 3 years
Secondary outcomes (3)
Number of Times a Telemedicine Visit Triggered Action
To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
Measured: 3 years
Number of Patients to Have Cytokine Release Syndrome
Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
Measured: 3 years
Number of Patients to Have Neurotoxicity
Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study startDec 2020 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Principal investigator decided not to pursue trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakhee Vaidya, MBBS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503538
- Sponsor's protocol ID
- IRB00067341
- Other IDs
- WFBCCC 99520
- Status last verified
- Oct 2020
- First submitted
- 4 Aug 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
- ClinicalTrials.gov ID
- NCT04503538
- Acronym / sponsor ID
- IRB00067341
- Conditions
- Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
- Keywords
- Relapsed large B-cell lymphoma, Refractory large B-cell lymphoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator decided not to pursue trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- 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.
The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.
Detailed description
Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient)
Secondary Objective(s)
- To determine how many times a telemedicine visit triggered an action (inpatient admission/ outpatient observation status)
- To determine how many patients were detected to have cytokine release syndrome and/or neurotoxicity based on their telemedicine visit
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T cell therapy and Telemedicine | Other | Other: Telemedicine visitAll outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma
- Age ≥ 18 years
- ECOG or Karnofsky performance status of ≤ 2
- Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion
- Patients must stay within a 30-minute distance from the cancer center
Key exclusion criteria (4 listed)
- Patients who have acute lymphoblastic leukemia/lymphoma
- Patients who have a high tumor burden (> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient
- Patient or caregiver unable to understand and follow English language
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Telemedicine visitParticipants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit. | Other | CAR-T cell therapy and Telemedicine |
Primary outcome
Number of Successfully Completed Telemedicine Visits
Time frame: 3 years
To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.
3 secondary outcomes
Number of Times a Telemedicine Visit Triggered Action
Time frame: 3 years
Number of Patients to Have Cytokine Release Syndrome
Time frame: 3 years
Number of Patients to Have Neurotoxicity
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Rakhee Vaidya, MBBS principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine visit in people with Large B-cell Lymphoma and Diffuse Large B Cell Lymphoma, run by Wake Forest University Health Sciences.
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 8 inclusion and 4 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: withdrawn, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Successfully Completed Telemedicine Visits (time frame: 3 years). 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 23 Oct 2020.