B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Antibodies; Rituximab

Criteria

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