DEC-MDS version 1.0
Research type
Research Study
Full title
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure (DEC-MDS)
IRAS ID
41720
Contact name
Ghulam J Mufti
Sponsor organisation
King's College London
Eudract number
2009-017098-40
Research summary
Myelodysplastic Syndromes (MDS) are a group of diseases in which the bone marrow is not producing enough normal blood cells. The bone marrow is the place where blood cells are made. In MDS, abnormal (or ??myelodysplastic?Â) bone marrow cells are produced as well as normal bone marrow cells. These abnormal bone marrow cells cannot make enough red blood cells, white blood cells and/or platelets. 5-azacitidine is the only drug which has been demonstrated to prolong the overall survival of patients with higher risk myelodysplastic syndromes (MDS) patients, including the French-American-British (FAB) classification of refractory anemia with excess of blasts in transformation (RAEB-t) (20-30% bone marrow blasts) and chronic myelomonocytic leukaemia (CMML). However, approximately half of patients do not respond to 5-azacitidine, and the treatment options for these patients are usually limited to supportive care with blood transfusions only. There is preliminary evidence to indicate that decitabine may be effective in the treatment of some patients who have failed to respond to 5-azacitidine therapy. We aim to conduct a clinical trial on 50 MDS patients, CMML-2 patients and AML patients with 20-30% bone marrow blasts (previously classified as RAEB-t by the FAB MDS classification) to evaluate the proportion of patients who will respond to decitabine therapy after having previously failed treatment with 5-azacitidine. This is a multi-centre study, and participants will be recruited from haematological centres in the United Kingdom with expertise in the diagnosis and treatment of MDS.
REC name
London - Dulwich Research Ethics Committee
REC reference
10/H0808/76
Date of REC Opinion
2 Jul 2010
REC opinion
Favourable Opinion