Astral-3: SGI-110 versus Treatment Choice in Adults with MDS or CMML
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents
IRAS ID
218200
Contact name
Ian Gabriel
Contact email
Sponsor organisation
Astex Pharmaceuticals, Inc.
Eudract number
2015-005257-12
Clinicaltrials.gov Identifier
EudraCT number, 2015-005257-12; IND number, 102743
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
This study will investigate the efficacy and safety of a new medication called guadecitabine (SGI-110) in patients with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukaemia (CMML) who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both, by comparing guadecitabine to current treatment choice/standard of care.
Normally, blood cells are made in the bone marrow in an orderly and controlled way. However, for people who suffer from MDS, their bone marrow does not produce enough healthy blood cells.While MDS is relatively uncommon in the general population, the incidence increases with age, therefore it is often more complicated to manage as there is a lessened ability to tolerate intensive treatment due to the presence of one or more non-cancerous diseases that occurs simultaneously with MDS . Patients with MDS have an increased risk of acute leukemia (a serious and life threatening blood cancer). Overall survival in patients with MDS is also reduced.
CMML is characterised as having too many monocytes , a type of blood cell produced in the bone marrow that helps the other blood cells remove damaged tissue in the blood. Prognosis is generally poor in CMML patients, with an average survival of 12 to 19 months.
At present, there are no approved treatment options for patients with MDS or CMML who progress on or relapse after azacitidine and decitabine therapy (decitabine is not availaible in the United Kingdom currently) The aim of this study is to compare the study medication, guadecitabine, to standard treatment choices which are: standard intensive chemotherapy, low dose cytarabine (the standard of care in elderly patients with Acute Myeloid Leukaemia (AML)) or best supportive care, as per standard hospital practices.
We are interested in whether guadecitabine may be more effective and safer than these treatment choices. The only way we can address these questions with confidence and without bias, is by conducting a large clinical study in which consenting patients are randomly assigned to the treatment groups and their outcome of these different approaches are compared across time.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0034
Date of REC Opinion
3 May 2017
REC opinion
Further Information Favourable Opinion