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Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486
Myelodysplastic Syndrome (MDS) is a group of blood disorders where the bone marrow does not produce enough mature red blood cells, white blood cells and platelets. In a healthy person, the bone marrow makes blood stem cells (immature cells, also called 'blasts') that become mature blood cells over time. In people with MDS, this process is affected and immature blood cells in the bone marrow do not mature fully to become healthy blood cells. This causes a lack of healthy blood cells that can function properly. With fewer healthy blood cells, infection, anaemia, or easy bleeding may occur. MDS can progress to acute myeloid leukaemia in 25-30% of patients, and if untreated it can be rapidly fatal. The purpose of this study is to evaluate the standard treatment, azacitidine (Vidaza) given as an injection under the skin compared to the same medication (called CC-486) taken as a tablet by mouth. Vidaza is approved by the Australian Therapeutics Goods Administration (TGA) as standard treatment for MDS. CC-486 is an experimental treatment. This means it is not an approved treatment for MDS in Australia. CC-486 is being developed to increase convenience and make it easier for patients to continue their treatment. So far it has been given to over 870 patients in studies across the world. The treatment in the injection and the tablet is the same. Studies like this one are being done to ensure the tablet works in the same way as the standard injected treatment. Vidaza is given by subcutaneous injection (ie under the skin) over an hour for 7 days every 4 weeks for as long as it continues to work. All study participants will receive active treatment (there is no placebo), and all participants will receive the standard injection for six treatment cycles followed by the new tablet medication taken once daily for 21 days every 4 weeks. This allows the researchers to compare the two ways of giving the medicine.
Details
| Lead sponsor | Kirby Institute |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Sep 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
Interventions
- Azacitidine
- CC-486
Countries
Australia