Myelodysplastic syndromes (MDS) Cancer Neoplasms
Conditions
Interventions
Epigenetic treatment of MDS with demethylating agents has achieved remarkable clinical responses and seems to be superior to supportive care or intensive chemotherapy. Low-dose 5-azacytidine was the f
Sponsors
Heinrich-Heine-University (Germany)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary Myelodysplastic Syndromes (pMDS) with unfavourable risk profile (more than 10% blast cells in the bone marrow, unfavourable karyotype) 2. Therapy-related (secondary) Myelodysplastic Syndromes (sMDS) 3. Chronic Myelomonocytic Leukaemia (CMML) 4. De-novo or secondary acute myeloid leukemia in elderly patients who cannot be treated with intensive chemotherapy
Exclusion criteria
Exclusion criteria: 1. Impaired liver or kidney function 2. Pregnancy 3. Simultaneous participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/toxicity, assessed at one year after treatment start. | — |
Secondary
| Measure | Time frame |
|---|---|
| All endpoints will be assessed at one year after treatment start: 1. Haematological response 2. Progression-free survival 3. Overall survival | — |
Countries
Germany
Outcome results
None listed