Metoprolol Treatment for Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
NCT ID: NCT04082910
Last Updated: 2022-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2019-09-15
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conditional therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Metoprolol
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
metoprolol, infliximab, etanercept, tocilizumab and/or other agents
During the term of metoprolol use, antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited to be used under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Prophylactic therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Metoprolol
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
metoprolol, infliximab, etanercept, tocilizumab and/or other agents
During the term of metoprolol use, antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited to be used under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Interventions
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Metoprolol
Metoprolol was given in patients who received CAR T cell therapy for CRS control or CRS precaution.
metoprolol, infliximab, etanercept, tocilizumab and/or other agents
During the term of metoprolol use, antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited to be used under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Significant bradycardia (heart rate \< 45/min)
* Cardiogenic shock
* Severe or acute heart failure
* Poor peripheral circulation perfusion
* Grade II or III atrioventricular block
* Sick sinus syndrome
* Severe peripheral vascular disease
16 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Han weidong
Principal Investigator
Locations
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Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHN-PLAGH-BT-044
Identifier Type: -
Identifier Source: org_study_id
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