FLIGHT

A multicentre randomised trial of first line treatment pathways for newly diagnosed Immune thrombocytopenia to compare standard steroid treatment against combined steroid and mycophenolate.

Background

FLIGHT is a study of two treatment pathways for patients with newly diagnosed Immune thrombocytopenia (ITP), which causes bruising and bleeding due to a low platelet count. It will compare standard steroid treatment versus combined steroid and mycophenolate (MMF).

Patients are first given high dose steroids but most suffer side effects. In addition, the majority of patients become ill again when the steroids are stopped: about 20% stay well long term. First line treatment for ITP is unsatisfactory, but has been unchallenged for decades.

As ITP is relatively rare, non-cancerous and the rare impact on survival of ITP have prevented it being a research funding priority, this underestimates the profound adverse impact an ITP diagnosis and its treatment has on patients; many of whom are young.

Diagnosis vs. current practice

MMF is often used as the next stage treatment for ITP and it works well. However, it can take up to two months to work during which patients continue to be at risk of bleeding, bruising, fatigue and usually need more steroids which they find intolerable.

They are required to come to hospital for weekly blood tests and for many this impacts on work. We want to find out whether it would benefit more patients if everyone takes MMF at diagnosis instead of current practice (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 patients given MMF right at the start of their treatment. 120 patients from 20 different hospitals will be asked to take part and half will be randomly chosen for the new pathway.

Public involvement

This clinical trial is supported by the ITP Support Association (only UK charity for ITP), a patient and public group; the founder is a co-applicant. Its website is an important source of support and information. We will use this link to optimise communication and feedback from the patients and public during and after this trial.

We also have a group of local patients in Bristol who helped inform the design of the study and reviewed the patient information sheets; we will continue to meet with them throughout. The study is supported by the UK ITP forum, a national group of expert ITP clinicians. We expect the results will be able to improve care for patients with ITP within five years.

Independently funded

Importantly, this is the first independently funded UK multicentre clinical trial for ITP and represents a big step forward for research into this condition.

If successful, we expect it to be the platform for further clinical trials in ITP enabling this patient group to experience improvements in care seen in other conditions where patients are offered recruitment to clinical trials as standard of care.