Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate (FLIGHT)
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|ClinicalTrials.gov Identifier: NCT03156452|
Recruitment Status : Not yet recruiting
First Posted : May 17, 2017
Last Update Posted : May 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Mycophenolate Mofetil Drug: Prednisolone||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A multicentre, open label randomised clinical trial of MMF with steroid as a first line treatment for patients with ITP against the standard care pathway involving steroids alone as first line treatment.|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Randomised Trial of First Line Treatment Pathways for Newly Diagnosed Immune Thrombocytopenia: Standard Steroid Treatment Versus Combined Steroid and Mycophenolate|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Steroid & Mycophenolate mofetil 1st line
Mycophenolate mofetil: 1 gm bd Non-IMP Steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks.
Drug: Mycophenolate Mofetil
500 mg and 250mg tablets for oral administration
Active Comparator: Prednisolone (Steroid) alone 1st line
Non-IMP steroid: 1mg/kg od 4 days (maximum of 100mg), 40mg od 2 weeks, 20mg od 2 weeks, 10mg od 2 weeks, 5mg od 2 weeks then 5mg alternate days 2 weeks.
5mg tablets for oral administration
Other Name: Steroid
- Time from randomisation to treatment failure. [ Time Frame: 1 year ]To include patients who are refractory (platelet count <30x109/L in spite of 2 weeks treatment in the steroid arm or platelet count <30x109/L in spite of 2 months treatment in the steroid +MMF arm) or who initially respond but then relapse (defined clinically as platelet count <30x109/L and need for further therapy).
- Remission rates [ Time Frame: Up to 12 months post randomisation ]Platelet count >30 x109/L and at least 2 fold increase from baseline. Complete >100x10 9/L, partial 30-100x10 9/L
- Time to next therapy [ Time Frame: Up to 12 months post randomisation ]Clinically relapse (as platelet count <30x109/L) and need for further therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156452
|Contact: Julie C Pellfirstname.lastname@example.org|
|Contact: Katharine Wale||0117 342 0231||ResearchApprovals@UHBristol.nhs.uk|
|Study Director:||Charlotte Bradbury||University of Bristol|