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| Name | Class |
|---|---|
| Janssen-Cilag Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | 20mg/m2/day, one hour intravenous infusion, every day during 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3 |
| Measure | Description | Time Frame |
|---|---|---|
| Response duration | ||
| Time to progression to AML | ||
| Survival |
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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:
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:
With informed consent
Negative pregnancy and adequate contraception if relevant
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Solary, MD, PhD | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Thorsten Braun, MD,PhD | Avicenne Hospital, 93 000 Bobigny | Principal Investigator |
| Ingrid Lafon, MD | CHU Le Bocage, Dijon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR La Source orléans | Orléans | Orléans | 45067 | France | ||
| CHU d'Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23690417 | Derived | Itzykson 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. | |
| 21828134 |
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| Toxicity (hematological and non-hematological) |
| Amiens |
| 80054 |
| France |
| CH Angers | Angers | 49 000 | France |
| Hôpital Avignon | Avignon | 84000 | France |
| Hopital de la Cote Basque | Bayonne | 64100 | France |
| Hôpital Avicenne | Bobigny | 93009 | France |
| CHU Haut-Lévèque | Bordeaux | 33604 | France |
| Hôpital Boulogne Sur Mer | Boulogne-sur-Mer | 62321 | France |
| Hopital d'Instruction des Armées Percy | Clamart | 92140 | France |
| CHU de | Clermont-Ferrand | 63058 | France |
| Centre Hospitalier Sud-Francilien | Corbeil-Essonnes | 91106 | France |
| Hopital Henri Mondor | Créteil | 94000 | France |
| CHU de Dijon | Dijon | 21034 | France |
| Hôpital Versailles | Le Chesnay | 78157 | France |
| Centre Hospitalier du Mans | Le Mans | 72037 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| CHU de nantes | Nantes | 44093 | France |
| Hôpital Archet1 | Nice | 06202 | France |
| CHU Caremeau | Nîmes | 30029 | France |
| Hopital Cochin | Paris | 75014 | France |
| Hopital Necker | Paris | 75015 | France |
| Hopital Hotel Dieu | Paris | 75181 | France |
| Hoiptal St Louis | Paris | 75475 | France |
| Hôpital Saint-Antoine. | Paris | 75571 | France |
| Centre Hospitalier Joffre | Perpignan | 66046 | France |
| CHU de Reims | Reims | 51092 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Hematology Dpt, Hopital Purpan | Toulouse | 40031 | France |
| CHU Bretoneau | Tours | 37044 | France |
| Institut gustave Roussy | Villejuif | 94805 | France |
| CHU de Bicêtre | Le Kremlin-Bicêtre | Île-de-France Region | 94275 | France |
| Derived |
| Braun 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. |
| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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