Status:
COMPLETED
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Lead Sponsor:
Fondazione Italiana Sindromi Mielodisplastiche-ETS
Collaborating Sponsors:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Conditions:
Chronic Myelomonocytic Leukemia
Eligibility:
All Genders
18-95 years
Phase:
PHASE2
Brief Summary
The study aims to assess the activity of decitabine in the treatment of CMML.
Eligibility Criteria
Inclusion
- Patients aged 18 and older
- CMML diagnosis according to WHO criteria
- 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
- Citogenetic abnormality other then t(5;12) (q33;p13)
- Anemia (Hb\<10g/dl)
- Thrombocytopenia (Plt\<100000/mm3)
- Splenomegaly(\>5cm below costal margin)
- Extramedullary localization
- Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
- Performance Status ECOG 0,1 or 2
- Estimated life expectancy\>=6 months
- 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
- Adequate renal function:
- Serum creatinine \< 1.5 times limit of normal
- Creatinine clearance \> 30ml/min
- Informed consent
- Negative pregnancy test or adequate contraception methods
Exclusion
- Myeloproliferative/myelodisplastic syndome othe than CMML
- Acute blastic transformation of CMML with bone marrow blast cells\>20%
- Patients eligible for allogenic bone marrow transplantation with identified donor
- CMML with t(5;12) o PDGFBR rearrangement
- Intensive chemotherapy given less than 3 months before
- Previous treatment with hypomethylating agent
- Age\< 18 years old
- Pregnancy or breastfeeding
- Performance Status ECOG\>2
- Estimate life expectancy\<6 months
- HIV infection
- Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
- Serious concomitantsystemic 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01251627
Start Date
April 1 2010
End Date
June 1 2018
Last Update
June 25 2018
Active Locations (21)
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1
Ematologia, Ospedale SS Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15121
2
AOU Ospedali Riuniti di Ancona
Ancona, Italy, 60131
3
Ematologia AOU Policlinico di Bari
Bari, Italy, 70124
4
Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola
Bologna, Italy, 40100