NCT03156452: FLIGHT

Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate

Completed Phase 3 Last updated 26 October 2022

What this trial tests

Phase 3 trial testing Mycophenolate Mofetil in Immune Thrombocytopenia in 123 participants. Completed in 5 March 2020.

Timeline

25 October 2017

Primary endpoint
5 March 2020

5 March 2020

Quick facts

Lead sponsor	University Hospitals Bristol and Weston NHS Foundation Trust
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	25 October 2017
Primary completion	5 March 2020
Estimated completion	5 March 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
• Prednisolone — full drug profile →

Conditions studied

• Immune Thrombocytopenia — all drugs for Immune Thrombocytopenia →

Sponsor

University Hospitals Bristol and Weston NHS Foundation Trust

Who can join

16 and older, any sex, with Immune Thrombocytopenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a study of two treatment pathways \[Standard steroid treatment versus combined steroid and Mycophenolate (MMF)\] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). ITP is an illness that causes bruising and bleeding due to a low platelet count (blood cells essential for normal clotting). Patients are first given high dose steroids but most suffer side effects (e.g. difficulty sleeping, weight gain, moods swings, high blood pressure and diabetes). In addition, the majority of patients become ill again when the steroids are stopped - only about 20% stay well long term. ITP is relatively rare, non-cancerous in nature and the rare impact on survival of ITP have prevented it from being a priority for research funding, with first line treatment being unsatisfactory and unchallenged for decades. This underestimates the profound adverse impact an ITP diagnosis and its treatment has on individual patients, many of whom are young.

MMF is often used as the next stage treatment for ITP and it works well. However, it can take up to 2 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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mycophenolate Mofetil for First-Line Treatment of Immune Thrombocytopenia.
   Bradbury CA, Pell J, Hill Q, Bagot C, et al · · 2021 · cited 70× · PMID 34469646 · DOI 10.1056/nejmoa2100596
2. Understanding Immune Thrombocytopenia: Looking Out of the Box.
   Schifferli A, Cavalli F, Godeau B, Liebman HA, et al · · 2021 · cited 16× · PMID 34249957 · DOI 10.3389/fmed.2021.613192
3. Trial protocol: a multicentre randomised trial of first-line treatment pathways for newly diagnosed immune thrombocytopenia: standard steroid treatment versus combined steroid and mycophenolate. The FLIGHT trial.
   Pell J, Greenwood R, Ingram J, Wale K, et al · · 2018 · cited 14× · PMID 30341143 · DOI 10.1136/bmjopen-2018-024427
4. Efficacy and safety of treatments in newly diagnosed adult primary immune thrombocytopenia: A systematic review and network meta-analysis.
   Wang Y, Sheng L, Han F, Guo Q, et al · · 2023 · cited 11× · PMID 36578882 · DOI 10.1016/j.eclinm.2022.101777