Overview

This trial is active, not recruiting.

Condition chronic myelomonocytic leukemia
Treatment decitabine
Phase phase 2
Sponsor Fondazione Italiana Sindromi Mielodisplastiche Onlus
Collaborator Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Start date April 2010
End date December 2011
Trial size 41 participants
Trial identifier NCT01251627, DECI2009-AISSM06

Summary

The study aims to assess the activity of decitabine in the treatment of CMML.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
decitabine
Decitabine will be administered at a dose of 20 mg/m2 infused over a 1 hour period once daily for 5 consecutive days. The totale amount per course is 100 mg/m2. Cycles will be administered every 4 weeks (1 cycle of 28 days).It is recommented that patients be treated for a minimum of 4 cycles.

Primary Outcomes

Measure
To assess the activity of decitabine in the treatment of CMML
time frame: 24 months

Secondary Outcomes

Measure
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
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

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 - Citogenetic abnormality other then t(5;12) (q33;p13) - Anemia (Hb<10g/dl) - Thrombocytopenia (Plt<100000/mm3) - Splenomegaly(>5cm below costal margin) - Extramedullary localization 4. 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 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 > 30ml/min 9. Informed consent 10. Negative pregnancy test or adequate contraception methods Exclusion Criteria: 1. Myeloproliferative/myelodisplastic syndome othe 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 (HBSAq positive) 13. 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

Additional Information

Official title A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Principal investigator Santini Valeria, Professor
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fondazione Italiana Sindromi Mielodisplastiche Onlus.