NCT01251627CompletedPhase 2
A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Fondazione Italiana Sindromi Mielodisplastiche-ETS21 sites in 1 country43 target enrollmentStarted: April 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 21
- Primary Endpoint
- To assess the activity of decitabine in the treatment of CMML
Study Overview
Brief Summary
The study aims to assess the activity of decitabine in the treatment of CMML.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Decitabine
Experimental
Eligible patients will recieve Dacogen 20mg/m2 in 1 hour iv infusion for 5 days every 28 days (1 cycle)plus Best Supportive Care.A total of 6 courses is planned.
Intervention: Decitabine (Drug)
Outcomes
Primary Outcomes
To assess the activity of decitabine in the treatment of CMML
Time Frame: 24 months
Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
Secondary Outcomes
- to assess the activity of decitabine in the treatment of CMML in terms of overall survival, time to leukemic transormation, response duration in terms of time to relapse after CR, PR, time to disease progression, ecc(24 months)
Investigators
Study Sites (21)
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