A study of Decitabine with or without Hydroxyurea in people with with advanced proliferative Chronic Myelomonocytic Leukemia (CMML)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 168

Inclusion Criteria

1- age 18 and older
2- CMML as defined by:
- Diagnosis according to WHO criteria
-Stable excess in blood monocytes, > 1 Giga/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.
And
- WBC = 13 G/L
And
- At least two of the following criteria: (adapted from Wattel et al. Blood 1996)
-Marrow blasts =5 %
-Clonal cytogenetic abnormality other than t(5;12) (q33; p13) and loss of Y chromosome
-ANC > 16 G/l in the absence of an active infection
-Anemia (Hb < 10 g/dL)
-Thrombocytopenia (platelet count < 100 G/L)
-Splenomegaly > 5 cm below costal margin (spleen size should also be measured by an imaging technique)
Or: Extramedullary localization (including documented cutaneous, pleural or pericardial effusion)
3- No prior treatment (except supportive care, or ESA, or short term (< 6 weeks) HY in patients presenting with high WBC counts)
4- Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
5- Adequate organ function including the following
-Liver : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis or due to Gilbert syndrome) , alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
-Renal : serum creatinine < 2 times ULN
6- Signed informed consent
7- Negative pregnancy and adequate contraception (including in male patients) if relevant.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

-Myeloproliferative / myelodysplastic syndrome other than CMML
-Patients eligible for allogeneic bone marrow transplantation with an identified donor
-CMML with t(5 ;12) or PDGF?R rearrangement that may be treated with imatinib
-Pregnant or breastfeeding
-Performance status > 2 on the ECOG Scale.
-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 stud
-Prior malignancy (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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