Clinical trial · Interventional
Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)
A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia
NCT01098084CI-TRIAL-00014070completedPhase 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 aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.
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
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3
Secondary outcomes (4)
- measure
- Response duration
- measure
- Time to progression to AML
- measure
- Survival
- measure
- Toxicity (hematological and non-hematological)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * CMML diagnosis according to WHO criteria * Stable excess in blood monocytes,\>1x10G/l and \>10% of WBC * Bone marrow blasts \<20% * Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation * With: * if WBC \< or= 12 000/mm3: IPSS high or intermediate 2 * if WBC \> 12 000/mm3: at least two of the following criteria: blast cells \> 5% in the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13), anemia (Hb \< 100 g/l), thrombocytopenia (platelet count \< 100G/l), splenomegaly \> 5 cm below costal margin, extramedullary localization * Either untreated or previously treated with * Hydrea or Etoposide given orally * non intensive chemotherapy * intensive chemotherapy given more than 3 months before inclusion * With performance status 0-2 on the ECOG scale * With estimated life expectancy of at least 12 weeks * With adequate organ function including the following: * Hepatic: total bilirubin \< 1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) \< 3 times ULN * Renal: serum creatinine \< 1.5 times ULN, creatinine clearance \> 30 ml/min * With informed consent * Negative pregnancy and adequate contraception if relevant Exclusion Criteria: * Myeloproliferative/myelodysplastic syndrome other than CMML * Acute blastic transformation of CMML with bone marrow blasts\>20% * Patients eligible for allogenic bone marrow transplantation with identified donor * CMML with t(5;12) or PDGFbetaR rearrangement that could receive Imatinib * Previous treatment with a hypomethylating agent * Age \< 18 years old * Pregnancy or breastfeeding * Performance status\> 2 on the ECOG Scale * Estimated life expectancy \< 12 weeks * Serious concomitant systemic disorder, 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 (2)
- DERIVEDItzykson R, Kosmider O, Renneville A, Gelsi-Boyer V, Meggendorfer M, Morabito M, Berthon C, Ades L, Fenaux P, Beyne-Rauzy O, Vey N, Braun T, Haferlach T, Dreyfus F, Cross NC, Preudhomme C, Bernard OA, Fontenay M, Vainchenker W, Schnittger S, Birnbaum D, Droin N, Solary E. Prognostic score including gene mutations in chronic myelomonocytic leukemia. J Clin Oncol. 2013 Jul 1;31(19):2428-36. doi: 10.1200/JCO.2012.47.3314. Epub 2013 May 20. PMID 23690417
- DERIVEDBraun T, Itzykson R, Renneville A, de Renzis B, Dreyfus F, Laribi K, Bouabdallah K, Vey N, Toma A, Recher C, Royer B, Joly B, Vekhoff A, Lafon I, Sanhes L, Meurice G, Orear C, Preudhomme C, Gardin C, Ades L, Fontenay M, Fenaux P, Droin N, Solary E; Groupe Francophone des Myelodysplasies. Molecular predictors of response to decitabine in advanced chronic myelomonocytic leukemia: a phase 2 trial. Blood. 2011 Oct 6;118(14):3824-31. doi: 10.1182/blood-2011-05-352039. Epub 2011 Aug 9. PMID 21828134