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Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders

Sponsor
Xuanwu Hospital, Beijing (Other)
Overall Status
Unknown status
CT.gov ID
NCT02021825
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
81
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects. Neurological assessment including the determination of the Expanded Disability Status Scale (EDSS) score and ophthalmologic evaluations were performed every 3 months and during relapses. Flow cytometric analysis, brain and spinal cord MRI was performed at baseline, 6, 12, 18, and 24 months.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders
Study Start Date :
Mar 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Other: MITO, annual relapse rate, safety

For refractory NMO patients aged 18-55, the initial dose 12 mg/m2 mitoxantrone was administered over a five day course every 3 months for 2 years (a total of eight courses). The initial dose was reduced to 9 mg/m2 if the preinfusion white-blood-cell count was 3.0-3.99 ×109/L,and to 6 mg/m2 if the white-blood-cell count was 2.0-2.99 ×109/L. No infusion if the white-blood-cell count was less than 2.0×109/L. The initial dose was reduced to 10 mg/m2 for nonhaematological toxic effects of WHO grade 2-3. Subsequent dose after 3 month was reduced to 10 mg/m2 for infections that occurred within 3 weeks of a previous infusion accompanied by a white-blood-cell count below 2×109/L, or to 8 mg/m2 for infections accompanied by white-blood-cell count of less than 1×109/L.

Drug: Mitoxantrone
The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects.
Other Names:
  • Novantrone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. annual relapse rate (ARR) [one year]

      ARR is defined as the number of confirmed relapses in a year. The number of annual relapse rate was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period.

    2. EDSS [six months]

      Expanded Disability Status Scale (EDSS) scores was used as parameters of effectiveness and was compared between premitoxantrone and postmitoxantrone treatment during the follow-up period.

    Secondary Outcome Measures

    1. Changes in LVEF [six months]

      - Assessment of cardiac function: Changes in LVEF by transthoracic echocardiography and determination of cardiac side effects by ECG and by measurement of CK-MB, Troponin and BNP.

    2. blood cell count [three months]

      - Assessment of hematological system: Monitoring blood cell count regularly. Considering marrow puncture if necessary.

    3. Flow cytometric analysis [six months]

      Immunofluorescent staining of wholeblood samples were performed of blood drawing using antibodies against CD3/CD4/CD8/CD19/CD20/CD56 with isotype controls, followed by lysis of red blood cells and immediate acquisition and analysis by flow cytometry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Recurrent longitudinal myelitis (>3 segments of spinal cord involvement by MRI) with or without recurrent ON (unilateral or bilateral) but with normal brain MRI and positive serological NMO IgG antibody.

    • Recurrent longitudinal myelitis (>3 segments of spinal cord involvement by MRI) with or without spatially limited brain lesion and positive serological NMO IgG antibody.

    • NMO, fulfilled Wingerchuk 2006 Criteria for NMO.

    • Patient presented at least 2 relapses during the 12 months preceding the start of mitoxantrone therapy, despite immunotherapies using corticosteroid, interferon beta, azathioprine, cyclophosphamide, Cyclosporin A, Mycophenolate Mofetil or a combination of these drugs

    • Extended Disability Status Score 3-8.

    • Normal range for white-blood-cell count (more than 4×109/L), neutrophil count (more than 2×109/L), and platelet count (more than 100×109/L).

    Exclusion Criteria:

    • Cardiac risk factors (e.g history of congestive heart failure and left ventricular ejection fraction (LVEF) < 50%

    • Systemic diseases such as lupus, Sjogren's syndrome, anti-phospholipid antibody syndrome, sarcoidosis, rheumatoid arthritis, or vitamin B12 deficiency

    • Previous treatment with mitoxantrone or anthracyclines

    • Pregnant or planning to be pregnant

    • Patients with severe liver disorders (WHO grade 4)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurology, Xuanwu Hospital, Capital Medical University Beijing Beijing China 100053

    Sponsors and Collaborators

    • Xuanwu Hospital, Beijing

    Investigators

    • Principal Investigator: Huiqing Dong, Doctor, Department of Neurology, Xuanwu Hospital, Capital Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xuanwu Hospital, Beijing
    ClinicalTrials.gov Identifier:
    NCT02021825
    Other Study ID Numbers:
    • MITONMO
    First Posted:
    Dec 27, 2013
    Last Update Posted:
    Dec 27, 2013
    Last Verified:
    Dec 1, 2013
    Keywords provided by Xuanwu Hospital, Beijing
    mitoxantrone
    neuromyelitis optica
    relapse
    Additional relevant MeSH terms:
    Neuromyelitis Optica
    Mitoxantrone

    Study Results

    No Results Posted as of Dec 27, 2013