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

AISSM ONLUS0 个研究点开始时间: 2009年11月2日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

AISSM ONLUS