RECRUITING

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Conditions

Optic Neuritis Myelitis Myelitis, Transverse Plasma Exchange Plasmapheresis Apheresis Pheresis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.

Official Title

A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Quick Facts

Study Start:2025-07-11

Study Completion:2031-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07100990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* ≥18 years of age * MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis * Visual acuity 20/200 or worse * Within 8 days of onset of visual symptoms * Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm) * Able to sign and date informed consent form * Willingness to comply with all study procedures and availability for the duration of the study	* Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation) * Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields * Pregnancy * Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis. * Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity) * Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer) * Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including: * Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization * Intravenous or subcutaneous immune globulin within 3 months of randomization * Plasma exchange within 3 months of randomization * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization * Teriflunomide use within prior 24 months * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide * Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)

Inclusion Criteria

Exclusion Criteria

* ≥18 years of age
* MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
* Visual acuity 20/200 or worse
* Within 8 days of onset of visual symptoms
* Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm)
* Able to sign and date informed consent form
* Willingness to comply with all study procedures and availability for the duration of the study

* Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
* Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields
* Pregnancy
* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity)
* Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)
* Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including:
* Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
* Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
* Intravenous or subcutaneous immune globulin within 3 months of randomization
* Plasma exchange within 3 months of randomization
* Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
* Teriflunomide use within prior 24 months
* Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
* Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)

Contacts and Locations

Principal Investigator

John Chen

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21218

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

John Chen, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-11

Study Completion Date2031-04-30

Study Record Updates

Study Start Date2025-07-11

Study Completion Date2031-04-30

Terms related to this study

Keywords Provided by Researchers

Plasma Exchange
Plasmapheresis
Apheresis
Pheresis

Additional Relevant MeSH Terms

Optic Neuritis
Myelitis
Myelitis, Transverse