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Clinical Trial Details — Status: Terminated

Administrative data

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

Study information

Verified date March 2024
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
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. For up to 5 patients in the study, standard plasma exchange (one plasma volume, up to 5 treatments, during 1-2 weeks) will be performed 2-3 weeks prior to start of Rituximab therapy. 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.

Locations

Country Name City State
Norway Department of Oncology and Medical Physics, Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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

Outcome

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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