B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome
This trial is active, not recruiting.
|Conditions||chronic fatigue syndrome, myalgic encephalomyelitis|
|Sponsor||Haukeland University Hospital|
|Start date||June 2010|
|End date||December 2015|
|Trial size||10 participants|
|Trial identifier||NCT01156922, 2010/1321|
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that severely affected chronic fatigue syndrome patients may benefit from B-cell depletion therapy using Rituximab induction with maintenance treatment.
The hypothesis is that at least a subset of chronic fatigue syndrome (CFS) patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
An approved amendment (April 15th 2011): the study will be extended with up to 5 patients. For up to 5 patients in the study, standard plasma exchange may be performed 2-3 weeks prior to start of B-lymphocyte depletion using Rituximab (as in the protocol).
Approved amendment (December 2011): 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes
time frame: Major response of at least six weeks duration, independent on when occuring, during the follow-up period
Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes.
time frame: At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention
Male or female participants from 18 years up to 66 years old.
Inclusion Criteria: - patients severely affected by chronic fatigue syndrome, in WHO performance status III or IV. - age 18-66 years - informed consent Exclusion Criteria: - patients with fatigue, not fulfilling criteria for CFS - 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 - 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 upper normal limit [UNL]) - reduced liver function (bilirubin or transaminases > 1.5 x UNL) - HIV positivity - evidence of clinically significant infection
|Official title||B-lymphocyte Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Severely Affected Chronic Fatigue Syndrome Patients. An Open Label Phase II Study With Rituximab Induction and Maintenance Treatment for Patients in WHO Performance Status III-IV|
|Principal investigator||Olav Mella, PhD, MD|
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