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Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

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ClinicalTrials.gov Identifier: NCT01098084
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : March 20, 2014
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by:
Groupe Francophone des Myelodysplasies

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Myelomonocytic Leukemia Drug: Decitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Official Title: A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia
Study Start Date : November 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
Experimental: Decitabine Drug: Decitabine
20mg/m2/day, one hour intravenous infusion, every day during 5 days




Primary Outcome Measures :
  1. 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 :
  1. Response duration
  2. Time to progression to AML
  3. Survival
  4. Toxicity (hematological and non-hematological)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098084


Locations
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France
CHU de Bicêtre
Le Kremlin-Bicêtre, Ile de France, France, 94275
CHU d'Amiens
Amiens, France, 80054
CH Angers
Angers, France, 49 000
Hôpital Avignon
Avignon, France, 84000
Hopital de la Cote Basque
Bayonne, France, 64100
Hôpital Avicenne
Bobigny, France, 93009
CHU Haut-Lévèque
Bordeaux, France, 33604
Hôpital Boulogne Sur Mer
Boulogne Sur Mer, France, 62321
Hopital d'Instruction des Armées Percy
Clamart, France, 92140
CHU de
Clermont Ferrand, France, 63058
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France, 91106
Hopital Henri Mondor
Creteil, France, 94000
CHU de Dijon
Dijon, France, 21034
Hôpital Versailles
Le Chesnay, France, 78157
Centre Hospitalier du Mans
Le Mans cedex, France, 72037
Institut Paoli Calmettes
Marseille, France, 13009
CHU de nantes
Nantes, France, 44093
Hôpital Archet1
Nice, France, 06202
CHU Caremeau
Nimes, France, 30029
CHR La Source orléans
Orléans, France, 45067
Hôpital Saint-Antoine.
Paris-Cedex 12, France, 75571
Hopital Cochin
Paris, France, 75014
Hopital Necker
Paris, France, 75015
Hopital Hotel Dieu
Paris, France, 75181
Hoiptal St Louis
Paris, France, 75475
Centre Hospitalier Joffre
Perpignan, France, 66046
CHU de Reims
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Hematology Dpt, Hopital Purpan
Toulouse, France, 40031
CHU Bretoneau
Tours, France, 37044
Institut gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Janssen-Cilag Ltd.
Investigators
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Study Chair: Eric Solary, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Thorsten Braun, MD,PhD Avicenne Hospital, 93 000 Bobigny
Principal Investigator: Ingrid Lafon, MD CHU Le Bocage, Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
First Posted: April 2, 2010    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2011

Keywords provided by Groupe Francophone des Myelodysplasies:
Decitabine, chronic myelomonocytic leukemia

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors