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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02021825
Recruitment Status : Unknown
Verified December 2013 by Xuanwu Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Study Description
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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
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders Drug: Mitoxantrone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
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 Name: Novantrone


Outcome Measures
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Primary Outcome Measures :
  1. annual relapse rate (ARR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: three months ]
    - Assessment of hematological system: Monitoring blood cell count regularly. Considering marrow puncture if necessary.

  3. Flow cytometric analysis [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021825


Contacts
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Contact: Huiqing Dong, Doctor +86-18611786966 shshtt@sina.com
Contact: Zheng Liu, Doctor +86-13910320552 lzwcy2003@aliyun.com

Locations
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China, Beijing
Department of Neurology, Xuanwu Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100053
Contact: Zheng Liu, Doctor    0086-13910320552    lzwcy2003@aliyun.com   
Principal Investigator: Huiqing Dong, Doctor         
Sponsors and Collaborators
Xuanwu Hospital, Beijing
Investigators
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Principal Investigator: Huiqing Dong, Doctor Department of Neurology, Xuanwu Hospital, Capital Medical University
More Information
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Publications:

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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02021825    
Other Study ID Numbers: MITONMO
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013
Keywords provided by Xuanwu Hospital, Beijing:
mitoxantrone
neuromyelitis optica
relapse
Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
 Immune System Diseases
Mitoxantrone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action