Chronic Fatigue Syndrome Clinical Trial
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
NCT number | NCT01156922 |
Other study ID # | 2010/1321 |
Secondary ID | |
Status | Terminated |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | June 2010 |
Est. completion date | April 2016 |
Verified date | March 2024 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 66 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Oncology and Medical Physics, Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
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. — View Citation
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 Treatmen — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes | The primary endpoint is defined as major response of the CFS symptoms, of at least six weeks duration, independent on when during 36 months follow-up the response period(s) occurs. Single such response periods, and the sum of these, are recorded. | Major response of at least six weeks duration, independent on when occuring, during the follow-up period | |
Secondary | Symptom alleviation, as compared to baseline, measured by standardized self-reports and quality of life schemes. | The secondary outcome measures are effect on the CFS symptoms, by evaluation at 3, 6, 10, 15, 20, 24, 30, and 36 months after first intervention (i.e. first Rituximab infusion) | At 3, 6, 10, 15, 20, 24, 30, 36 months after intervention |
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