Principal Investigator: Dr. Olav Mella, PhD, MD
Dept of Oncology, Haukeland University Hospital
Bergen, Norway, N-5021
Based on pilot patient observations, and experience from the prior study KTS-1-2008, the investigators anticipate that 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 CFS patients have an activated immune system involving B-lymphocytes, and that prolonged B-cell depletion may alleviate symptoms.
Study Start Date: September 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.