Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders
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|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
|Condition or disease||Intervention/treatment||Phase|
|Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders||Drug: Mitoxantrone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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.
- 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.
- blood cell count [ Time Frame: three months ]- Assessment of hematological system: Monitoring blood cell count regularly. Considering marrow puncture if necessary.
- 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.
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
|Contact: Huiqing Dong, Doctoremail@example.com|
|Contact: Zheng Liu, Doctorfirstname.lastname@example.org|
|Department of Neurology, Xuanwu Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100053|
|Contact: Zheng Liu, Doctor 0086-13910320552 email@example.com|
|Principal Investigator: Huiqing Dong, Doctor|
|Principal Investigator:||Huiqing Dong, Doctor||Department of Neurology, Xuanwu Hospital, Capital Medical University|