Overview

This trial is active, not recruiting.

Conditions chronic fatigue syndrome, myalgic encephalomyelitis
Treatment rituximab
Phase phase 2
Target CD20
Sponsor Haukeland University Hospital
Start date June 2010
End date December 2015
Trial size 10 participants
Trial identifier NCT01156922, 2010/1321

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Rituximab induction two infusions (500 mg/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. 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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Haukeland University Hospital.