patients with myelodisplastic syndrome MedDRA version: 9.1 Level: LLT Classification code 10054350 MedDRA version: 9.1 Level: LLT Classification code 10054350 MedDRA version: 9.1 Level: LLT Classification code 10054350 MedDRA version: 9.1 Level: LLT Classification code 10054350
Conditions
Interventions
Trade Name: Dacogen (decitabina)
Pharmaceutical Form: Powder for solution for injection
CAS Number: 2353335
Current Sponsor code: 2353335
Concentration unit: g/ml gram(s)/millilitre
Concentration type
Sponsors
AISSM ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 and older 2. CMML diagnosis according to WHO criteria 3. If WBC  12000/mm3: IPSS High or INT-2 If WBC 5% in the bone marrow Cytogenetic abnormality other than t(5;12) (q33; p13) Anemia (Hb 5 cm below costal margin) Extramedullary localization 4. Patients untreated or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion 5. Performance Status ECOG 0, 1 or 2 6. Estimated life expectancy ≥6 months 7. Adequate hepatic function: Total bilirubin 30 ml/min 9. Informed consent 10. Negative pregnancy test or adequate contraception methods 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Myeloproliferative/myelodysplastic syndrome other than CMML 2. Acute blastic transformation of CMML with bone marrow blast cells > 20% 3. Patients eligible for allogenic bone marrow transplantation with identified donor 4. CMML with t(5;12) o PDGFBR rearrangement 5. Intensive chemotherapy given less than 3 months before 6. Previous treatment with hypomethylating agent 7. Age 2 10. Estimate life expectancy < 6 months 11. HIV infection 12. Chronic active hepatitis secondary to HCV or HBV (HBSAg positive) 13. Serious concomitant systemic disorders, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess the activity of decitabine in the treatment of CMML. Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group (IWG) response criteria in myelodysplasia13;Secondary Objective: Secondary objectives of the trial are to assess the activity of decitabine in the treatment of CMML in terms of: Overall survival Time to leukemic transformation Response duration in terms of time to relapse after CR, PR Time to disease progression Response less than CR and PR evaluated according to IWG criteria for defining a haematology improvement (HI) Transfusion needs Safety of the treatment Quality of life Haematological and extra-haematological toxicity Relationship between biological marker (molecular and cytogenetic data) and efficacy of decitabine (response to therapy, time to progression, disease free survival and overall survival).;Primary end point(s): Response rate (CR+PR) evaluated according to 2006 IWG response criteria in myelodysplasia | — |
Countries
Italy
Outcome results
None listed