FLIGHT Study

A multicentre randomised trial of first line treatment pathways for newly diagnosed immune thrombocytopenia: Standard steroid treatment versus combined steroid and mycophenolate

Summary

Immune thrombocytopenia (ITP) is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). As treatment, patients are first given high dose steroids but most suffer side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure, diabetes etc). In addition, the illness doesn't get better for some patients, and the majority of others get ill again when the steroids are stopped. Only about 20% stay well long term.

Mycophenolate (MMF) is often used as the next treatment for ITP and it works quite well. However, it can take up to 2 months to work. In these 2 months patients are at risk of bleeding, bruising, feeling tired and usually need more steroids which they loathe. They have to come to hospital each week for blood tests and most have to take time off sick.

We want to find out whether more patients would feel better sooner if everyone takes MMF at diagnosis instead of what we do at the moment (waiting for the illness to come back). We plan to test this by comparing the current way we treat patients to a new way with all patients given MMF right at the start of their treatment. Patients from different hospitals will be asked to take part and half will be randomly chosen for the new pathway. Their normal hospital appointments will be used to record how well they are for a year. They will have no extra blood tests or appointments as a result of agreeing to take part.

We have a group of local patients in Bristol who have helped us and we will continue to meet with them throughout. We expect the results will be able to improve care for patients with ITP within 5 years.