Chronic Myelomonocytic Leukemia MedDRA version: 9.1 Level: LLT Classification code 10009018 Term: Chronic myelomonocytic leukaemia
Conditions
Interventions
Trade Name: DACOGEN (decitabine)
Product Name: DECITABINE
Product Code: JNJ-30979754
Pharmaceutical Form: Solution for injection
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 and older With CMML diagnosis according to WHO criteria -Stable excess in blood monocytes, > 1 x 109/L and constituting > 10% WBC - Lack of bcr-abl rearrangement (or Philadelphia chromosome) - Bone marrow blast cells or = 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 5 cm below costal margin -Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…) Either untreated or previously treated with -Hydrea or Etoposide given orally -Non intensive chemotherapy (e.g. low dose cytarabine) -Intensive chemotherapy given more than 3 months before inclusion With performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale. With estimated life expectancy of at least 12 weeks (this is inherent to ECOG 0-2, and actually very hard to predict/verify, therefore we prefer to take this out) With adequate organe function including the following -Hepatic : total bilirubin 30 mL/min With informed consent With negative pregnancy and adequate contraception 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Myeloproliferative / myelodysplastic syndrome other than CMML -Acute blastic transformation of CMML with bone marrow blast cells > 20% -Patients eligible for allogeneic bone marrow transplantation with a identified donor -CMML with t(5 ;12) or PDGF?R rearrangement that could receive imatinib -Intensive chemotherapy given within 3 months -Previous treatment with a hypomethylating agent -Age 2 on the ECOG Scale. -Estimated life expectancy lower than 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. -Consent withdrawal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hematological response rate at three and six cycles according to the IWG 2006 criteria (modified in case of “proliferative” CMML);Secondary Objective: Response duration Time to progression to AML Survival Clinical and biological toxicity Demethylation of LINE repetitive elements in vitro and in vivo characterization of the response of two blood monocyte populations to decitabine. ;Primary end point(s): Hematological response rate at three and six cycles according to the IWG 2006 criteria (modified in case of “proliferative” CMML) If the treatment has demonstrated efficacy, additional courses will be given with no limitation in number, but a recommendation to administer at least 6 courses after the best response has been reached. | — |
Countries
France
Outcome results
None listed