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A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

Phase 2
18 Years
95 Years
Open (Enrolling)
Chronic Myelomonocytic Leukemia

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Trial Information

A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the activity of decitabine in the treatment of CMML

Outcome Description:

Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Santini Valeria, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

U.O di Ematologia, AO of Careggi, viale Morgagni n.85-50134-Firenze


Italy: National Monitoring Center for Clinical Trials-Ministery Health

Study ID:




Start Date:

April 2010

Completion Date:

December 2012

Related Keywords:

  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Decitabine
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Leukemia, Myelomonocytic, Acute