Cyclophosphamide by myalgic encephalomyelitis / chronic fatigue syndrome (ME / CFS)
Cyclophosphamide BY myalgic encephalomyelitis / chronic fatigue syndrome (ME / CFS)
Part A, for up to 30 patients with ME / CFS: An open phase II trial with 6 cyclophosphamide infusions 4 weeks apart
Part B, for up to 20 patients with severe and very severe ME / CFS: An exploratory study with up to 6 cyclophosphamide infusions 4 weeks apart, in collaboration with local health services
The purpose of this study is to investigate whether cyclophosphamide infusions given every four weeks is associated with clinically significant responses and acceptable side effects in ME / CFS patients, and whether such treatment if necessary. Workable in patients with severe and very severe ME / CFS. The primary endpoint will be based on patients' self-report of symptom development.
The application relates Part A: An open-label phase II study for up to 30 patients with ME / CFS (not mild) with six infusions cyclophosphamide every fourth week, 12 months follow-up. If at least 40% response rate in Part A, then part B: A descriptive study with up to 20 patients with severe and very severe ME / CFS, with the same treatment, but where monitoring and intervention carried out in collaboration with healthcare close patient home.
(Project Manager project)
Ref. No .: 2014/1672 EudraCT Number: 2014-004029-41 Project start: 01.01.2015 Project End: 30/06/2017
Treatment Status: Approved
Research Status: Ongoing
Project: Øystein Fluge
Research Responsible (s): Haukeland University Hospital
Initiator: Contributions Research
Study researcher initiated. There is no external sponsor of the clinical trial. Research Group for ME / CFS Oncology Haukeland University Hospital has support from the Kavli Foundation, essential for research purposes to better understand the pathogenetic mechanisms of ME / CFS. Kavli Fund has granted a 50% nurse position for 12 months., To help with the study. This is thought transferred to clinical research Post by HUS which will then be responsible for implementation and interventions (study Part A) in collaboration with the study management at Oncology, HUS.
Drug costs are very low (less than 200 NOK per infusion), ie 1200 NOK per patient for the entire treatment, and will be covered over the research group for ME / CFS Oncology their budget. It is drawn own drug insurance for study. There is no financial compensation for study participants.
Research Data: Drug Testing, Human biological material Humans
Selection: Patients / clients