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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-15

Study Completion Date

2023-12-30

Brief Summary

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The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.

Detailed Description

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Conditions

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Solid Tumor Hematological Malignancy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Metoprolol

Intervention Type DRUG

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

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Metoprolol

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.

Exclusion Criteria

Patients with contraindications indicated in metoprolol instruction, including:

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han weidong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weidong Han, M.D.

Role: CONTACT

+861066939711

Facility Contacts

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Weidong Han, M.D

Role: primary

+861066939711

Qingming Yang, M.D

Role: backup

+861066939460

Other Identifiers

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CHN-PLAGH-BT-044

Identifier Type: -

Identifier Source: org_study_id

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