Clinical trial · Interventional
Multicenter Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
NCT01251627CI-TRIAL-00033402DECI2009completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to assess the activity of decitabine in the treatment of CMML.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine
- description
- 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.
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- To assess the activity of decitabine in the treatment of CMML
- timeFrame
- 24 months
- description
- 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 (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.