Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

Overview

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

Full Title of Study: “A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: Decitabine
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Italiana Sindromi Mielodisplastiche-ETS
  • Collaborator
    • Centro di Riferimento per l’Epidemiologia e la Prev. Oncologica Piemonte
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Santini Valeria, Professor, Principal Investigator, U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze

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