CycloME part A
The Cyclophosphamide trial is a single centre study. The Dept. of Oncology at Haukeland University Hospital is the only study centre assessing and including patients in the trial. In addition, the Norwegian Radium Hospital is taking part in the trial as a treatment centre, administering treatments to a small group of patients resident in the Oslo area.
The CycloME trial is an unblinded study, which means all participants receive treatment with the active substance. Each patient receives six intravenous treatments four weeks apart, and follow-up for a total of one year. The participants complete examinations and tests before and after treatment, and they submit regular reports on any changes in symptoms and physical function.
The purpose of the study is to investigate the effects and side effects of cyclophosphamide in a group of patients suffering from ME/CFS.
40 patients with moderate to severe ME will participate in the trial.
Status, CycloME part A
The medical intervention phase has been completed, and all participants are now in the follow-up phase.
We have applied for an extension of the follow-up period by 6 additional months, thus completing the trial in July 2017.
We are aiming to publish the results from the CycloME trial, part A, in 2017.
CycloME part B
In the event that the interim results from CycloME part A should indicate a clinically relevant response/improvement in symptoms in a minimum of 40 % of the patients, the trial may be extended to include patients with very severe ME. In part B, both treatment and follow-up will be completed in collaboration with the patient's local primary health service. Unfortunately, we cannot accept any further applications for participation in the study.
Based on an analysis of the preliminary response and toxicity data from CycloME, part A, we have concluded that in order to extend the trial to include patients with severe to very severe ME, we need to adjust the protocol and plan the intervention and follow-up of each patient with great care. In order to gain more experience with this highly vulnerable group of patients, we are planning a pilot study involving a smaller number of participants. The change of protocol will be subject to approval by the Regional Ethics’ committee and the Norwegian Medicines Agency. We will select candidates for participation in the pilot study from the list of candidates for CycloME part B, and will contact the relevant candidates directly.