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Spots Global Cancer Trial Database for Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes

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Trial Identification

Brief Title: Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes

Official Title: Evaluation of Haematological Improvement in Patients With Low-risk MDS by Comparing VBaP With Danazol in Patients Who Have Either Received Erythropoiesis Stimulating Agents (ESA) and Lost Response, Not Responded to ESA or Are Deemed Unlikely to Respond to ESA

Study ID: NCT04997811

Study Description

Brief Summary: Over 7,000 people in the UK are living with Myelodysplastic Syndromes (MDS). Approximately 1,600 of these individuals (23%) die each year from their disease. MDS affects the production of blood cells by the bone marrow, causing chronic fatigue, bleeding, and recurrent infections. Many patients die because their disease transforms into acute myeloid leukaemia (AML) an even more aggressive blood cancer. The general outlook for AML is poor, but when AML arises from MDS it is worse. REPAIR-MDS seeks to repurpose existing drugs in order to dramatically improve the outlook, health and quality of life of people with MDS. The trial treatments aim to improve the production of healthy functioning blood and immune cells that will fight against infections and boost the immune system's action against the MDS clone. REPAIR-MDS design is a is a multicentre open label phase 2 randomised controlled trial which will compare VBaP (sodium valproate, bezafibrate, medroxyprogesterone) with danazol in patients who have received either Erythropoiesis Stimulating Agents (ESAs) and lost response, not responded to ESAs or are deemed unlikely to respond to ESAs.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Heartlands Hospital, Birmingham, Bordesley Green East, United Kingdom

Royal Cornwall Hospital NHS Trust, Truro, Cornwall, United Kingdom

University Hospitals Dorset NHS Foundation Trust, Poole, Dorset, United Kingdom

Russells Hall Hospital, Dudley, England, United Kingdom

University College London Hospitals NHS Foundation Trust, London, England, United Kingdom

King's College Hospital NHS Foundation Trust, London, England, United Kingdom

Broomfield Hospital, Chelmsford, Essex, United Kingdom

Colchester General Hospital, Colchester, Essex, United Kingdom

Basingstoke and North Hampshire Hospital,, Basingstoke, Hampshire, United Kingdom

Royal Hampshire County Hospital, Hampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, United Kingdom

East Kent Hospitals University Foundation Trust, Canterbury, Kent, United Kingdom

James Paget University Hospitals NHS Foundation Trust, Gorleston-on-Sea, Norfolk, United Kingdom

Nottingham City Hospital, Nottingham University Hospitals NHS Trust, Hucknall Road, Nottingham, Nottinghamshire, United Kingdom

Grampian Health Board, Aberdeen, Scotland, United Kingdom

Good Hope Hospital, Birmingham, Sutton Coldfield, United Kingdom

Hull University Teaching Hospitals, Hull, , United Kingdom

Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom

James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, , United Kingdom

Royal Gwent Hospital, Aneurin Bevan University Health Board, Newport, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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