Inclusion Criteria:
- Age 18 or older
- CMML diagnosis according to WHO criteria
- Stable excess in blood monocytes,>1x10G/l and >10% of WBC
- Bone marrow blasts <20%
- Dysplasia of at least one lineage or clonality marker or blood monocytosis during
more than 3 months w/o other explanation
- With:
- if WBC < or= 12 000/mm3: IPSS high or intermediate 2
- if WBC > 12 000/mm3: at least two of the following criteria: blast cells > 5% in
the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13),
anemia (Hb < 100 g/l), thrombocytopenia (platelet count < 100G/l), splenomegaly
> 5 cm below costal margin, extramedullary localization
- Either untreated or previously treated with
- Hydrea or Etoposide given orally
- non intensive chemotherapy
- intensive chemotherapy given more than 3 months before inclusion
- With performance status 0-2 on the ECOG scale
- With estimated life expectancy of at least 12 weeks
- With adequate organ function including the following:
- Hepatic: total bilirubin < 1.5 times upper limit of normal (ULN), alanine
transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
- Renal: serum creatinine < 1.5 times ULN, creatinine clearance > 30 ml/min
- With informed consent
- Negative pregnancy and adequate contraception if relevant
Exclusion Criteria:
- Myeloproliferative/myelodysplastic syndrome other than CMML
- Acute blastic transformation of CMML with bone marrow blasts>20%
- Patients eligible for allogenic bone marrow transplantation with identified donor
- CMML with t(5;12) or PDGFbetaR rearrangement that could receive Imatinib
- Previous treatment with a hypomethylating agent
- Age < 18 years old
- Pregnancy or breastfeeding
- Performance status> 2 on the ECOG Scale
- Estimated life expectancy < 12 weeks
- Serious concomitant systemic disorder, including active bacterial, fungal or viral
infection, that in the opinion of the investigator would compromise the safety of the
patient and/or his/her ability to complete the study