Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)
This study has been completed.
Sponsor:
Groupe Francophone des Myelodysplasies
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT01098084
First received: April 1, 2010
Last updated: November 25, 2011
Last verified: March 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myelomonocytic Leukemia |
Drug: Decitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment |
| Official Title: | A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia |
Resource links provided by NLM:
Further study details as provided by Groupe Francophone des Myelodysplasies:
Primary Outcome Measures:
- 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 Outcome Measures:
- Response duration
- Time to progression to AML
- Survival
- Toxicity (hematological and non-hematological)
| Enrollment: | 41 |
| Study Start Date: | November 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Decitabine |
Drug: Decitabine
20mg/m2/day, one hour intravenous infusion, every day during 5 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098084
Locations
| France | |
| Hôpital Avicenne | |
| Bobigny, Ile de France, France, 93 009 | |
| CHU de Bicêtre | |
| Le Kremlin-Bicêtre, Ile de France, France, 94275 | |
| CHU Cochin | |
| Paris, Ile de France, France, 75679 | |
| CHU d'Amiens | |
| Amiens, France, 80054 | |
| CHU de Clermont-Ferrand | |
| Clermont-Ferrand, France, 63058 | |
| Centre Hospitalier Sud-Francilien | |
| Corbeil-Essonnes, France, 91106 | |
| CHU Henri Mondor | |
| Créteil, France, 94010 | |
| CHU le Bocage | |
| Dijon, France, 21000 | |
| Centre Hospitalier du Mans | |
| Le Mans, France, 72000 | |
| Hôpital Paoli-Calmettes | |
| Marseille, France, 13273 | |
| Hôpital Archet 1 | |
| Nice, France, 06202 | |
| CHU Caremeau | |
| Nimes, France, 30029 | |
| Hôpital Hôtel-Dieu | |
| Paris, France, 75181 | |
| Centre Hospitalier Maréchal Joffre | |
| Perpignan, France, 66046 | |
| CHU Haut-Lévêque | |
| Pessac, France, 33604 | |
| Hôpital Purpan | |
| Toulouse, France, 40031 | |
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Janssen-Cilag Ltd.
Investigators
| Study Chair: | Eric Solary, MD, PhD | Institut Gustave Roussy |
| Principal Investigator: | Thorsten Braun, MD,PhD | Avicenne Hospital, 93 000 Bobigny |
| Principal Investigator: | Ingrid Lafon, MD | CHU Le Bocage, Dijon |
More Information
No publications provided by Groupe Francophone des Myelodysplasies
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eric Solary, MD PhD, Unite INSERM 1009 Institut Gustave Roussy |
| ClinicalTrials.gov Identifier: | NCT01098084 History of Changes |
| Other Study ID Numbers: | GFM-DEC-LMMC-2007 |
| Study First Received: | April 1, 2010 |
| Last Updated: | November 25, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe Francophone des Myelodysplasies:
|
Decitabine, chronic myelomonocytic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Acute Neoplasms by Histologic Type Neoplasms Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases |
Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013