B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome
NCT ID: NCT01156909
Last Updated: 2014-09-01
Study Results
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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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2010-10-31
2014-02-28
Brief Summary
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The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab
Rituximab induction using two infusions (500mg/m2, max 1000 mg) two weeks apart, followed by maintenance Rituximab infusions (500 mg/m2, max 1000 mg) after 3, 6, 10 and 15 months.
Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.
Interventions
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Rituximab
Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period.
Eligibility Criteria
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Inclusion Criteria
* age 18-66 years
* informed consent
Exclusion Criteria
* pregnancy or lactation
* previous malignant disease except basal cell carcinoma of skin and cervical carcinoma in situ
* previous major immunological disease, except autoimmune diseases such as diabetes mellitus or thyroiditis
* previous long-term use of immunosuppressive drugs, except steroids e.g. in obstructive lunge disease
* endogenous depression
* lack of ability to comply by the protocol
* multi-allergy with risk of serious drug reaction
* reduced renal function (creatinin \> 1.5 x UNL)
* reduced liver function (bilirubin or transaminases \> 1.5 x UNL)
* HIV positivity
* evidence of clinically significant infection
18 Years
66 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Principal Investigators
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Olav Mella, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Haukeland University Hospital
Locations
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Department of Oncology, Haukeland University Hospital
Bergen, , Norway
Countries
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References
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Fluge O, Mella O. Clinical impact of B-cell depletion with the anti-CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28. doi: 10.1186/1471-2377-9-28.
Fluge O, Risa K, Lunde S, Alme K, Rekeland IG, Sapkota D, Kristoffersen EK, Sorland K, Bruland O, Dahl O, Mella O. B-Lymphocyte Depletion in Myalgic Encephalopathy/ Chronic Fatigue Syndrome. An Open-Label Phase II Study with Rituximab Maintenance Treatment. PLoS One. 2015 Jul 1;10(7):e0129898. doi: 10.1371/journal.pone.0129898. eCollection 2015.
Other Identifiers
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2010/1318
Identifier Type: -
Identifier Source: org_study_id
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