MedTrace Logo

Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes

NCT04997811 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-10-03

No results posted yet for this study

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.

Conditions

  • Myelodysplastic Syndromes (MDS)

Interventions

DRUG

Sodium Valproate, Bezafibrate, Medroxyprogesterone

Sodium valproate tablet 1 x 500mg bd, (starting 1 x 200mg bd) Bezafibrate standard release tablet 2 x 200mg tds, (starting 1 x 200mg tds) Medroxyprogesterone acetate tablet 1 x 400mg bd (starting 1 x 400mg od)

DRUG

Danazol

Danazol 1 x 200mg capsules tds, (starting 1 x 200mg od)

Sponsors & Collaborators

  • Blood Cancer UK

    collaborator UNKNOWN

  • Dudley Group NHS Foundation Trust

    collaborator OTHER

  • University of Birmingham

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Prof. Janet Dunn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997811 on ClinicalTrials.gov