Phase III multicentric open label study to assess the effectiveness of decitabine in the treatment of chronic myelomonocytic leukemia - DACOGENCML2002

• Conditions: patients with myelodisplastic syndrome; MedDRA version: 9.1Level: LLTClassification code 10054350

• Registration Number: EUCTR2009-014561-77-IT
• Lead Sponsor: AISSM ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 < 12000/mm3: at least two of the following criteria Blast cells > 5% in the bone marrow Cytogenetic abnormality other than t(5;12) (q33; p13) Anemia (Hb < 10 g/dl) Thrombocytopenia (Plt < 100000/mm3) Splenomegaly (> 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 < 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis) AST and ALT < 3 times limit of normal 8. Adequate renal function: Serum creatinine < 1.5 times limit of normal Creatinine clearance > 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

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 < 18 years old 8. Pregnancy or breastfeeding 9. Performance Status ECOG > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified