Inclusion Criteria:
- Age 18 years or older
- Chronic myelomonocytic leukemia (CMML) according to WHO criteria:
- Stable excess in blood monocytes > 1 G/L
- Lack of bcr-abl rearrangement (or Philadelphia chromosome)
- Bone marrow blast cells < 20%
- Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation
- Platelet counts < 50 G/L on two successive blood counts in the 2 weeks preceding inclusion
- Either of D1 or D2 criteria:
- Lack of features of advanced disease If white blood cell count (WBC) < 13 G/L: International Prognostic Scoring System (IPSS) low or intermediate-1
If WBC ≥ 13 G/L: no more than one of the following criteria:
- Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
- Absolute neutrophil count (ANC) > 16 G/L
- Anemia (Hb < 100 g/L)
- Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…) OR D2- Features of advanced disease If WBC < 13 G/L: IPSS intermediate-2 or high
If WBC ≥ 13 G/L: two or more of the following criteria:
- Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
- ANC > 16 G/L
- Anemia (Hb < 100 g/L)
- Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…) And having resisted (progression or stable disease without hematological improvement according to International Working Group (IWG) 2006 criteria) or relapsed after a treatment with a hypomethylating agent (azacitidine or decitabine for a minimum of 6 cycles)
- Blast cells ≤ 5% in the bone marrow
- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale
- Serum Creatinin < 2 times the upper limit of normal (ULN)
- Alanine transaminase (ALT) and aspartate transaminase (AST) < 3 ULN, total bilirubin < 1.5 ULN (except Gilbert Syndrome)
- Adequate contraception if relevant
- Signed informed consent
Exclusion Criteria:
- CMML with t(5 ;12) or Platelet-derived growth factor beta receptor (PDGFbetaR) rearrangement
- Acute blastic transformation of CMML with bone marrow blast cells > 20%
- Bone marrow blast cells > 5%
- Patients eligible for allogeneic bone marrow transplantation with an identified donor
- Intensive chemotherapy given less than 3 months before inclusion
- Pregnant or breastfeeding
- Hepatitis C infection
- Splenomegaly > 16 cm by ultrasound or CT scan (Not Applicable in patients without palpable splenomegaly)
- Significant (grade II-IV) myelofibrosis (bone marrow trephine if bone marrow aspirate with poor cellularity, or features of myelofibrosis on the peripheral blood smear (teardrop erythrocytes)
- Clinically relevant thromboembolic risk factor which, in the investigator's opinion, is such that the benefit/risk ratio becomes unfavourable if platelet counts increase
- Liver cirrhosis (Child-Pugh score ≥ 5)
- Prior Cancer (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
- 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.
- Hypersensitivity to Eltrombopag