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Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01098084
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : March 20, 2014
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
Allocation: N/A
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

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 identifier (NCT number): NCT01098084

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Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Janssen-Cilag Ltd.
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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 Identifier (NCT Number):
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Responsible Party: Eric Solary, MD PhD, Unite INSERM 1009 Institut Gustave Roussy Identifier: NCT01098084    
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, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors