Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

Study Overview
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Brief Summary
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The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.

Official Title
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A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

Conditions
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Chronic Myelomonocytic Leukemia

Intervention / Treatment
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* Drug: Decitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decitabine<br> | Drug: Decitabine<br>* 20mg/m2/day, one hour intravenous infusion, every day during 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration |  |  | 
| Time to progression to AML |  |  | 
| Survival |  |  | 
| Toxicity (hematological and non-hematological) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decitabine, chronic myelomonocytic leukemia