Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

March 19, 2014 updated by: Groupe Francophone des Myelodysplasies

A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU d'AMIENS
      • Angers, France, 49 000
        • CH Angers
      • Avignon, France, 84000
        • Hôpital Avignon
      • Bayonne, France, 64100
        • Hopital de la cote Basque
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Bordeaux, France, 33604
        • Chu Haut-Leveque
      • Boulogne Sur Mer, France, 62321
        • Hôpital Boulogne Sur Mer
      • Clamart, France, 92140
        • Hopital D'Instruction Des Armees Percy
      • Clermont Ferrand, France, 63058
        • CHU de
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud-Francilien
      • Creteil, France, 94000
        • Hopital Henri Mondor
      • Dijon, France, 21034
        • Chu de Dijon
      • Le Chesnay, France, 78157
        • Hôpital Versailles
      • Le Mans cedex, France, 72037
        • Centre Hospitalier du Mans
      • Marseille, France, 13009
        • Institut Paoli Calmettes
      • Nantes, France, 44093
        • CHU de Nantes
      • Nice, France, 06202
        • Hôpital Archet1
      • Nimes, France, 30029
        • CHU Caremeau
      • Orléans, France, 45067
        • CHR La Source orléans
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75015
        • Hopital Necker
      • Paris, France, 75475
        • Hoiptal St Louis
      • Paris, France, 75181
        • Hôpital Hôtel Dieu
      • Paris-Cedex 12, France, 75571
        • Hôpital Saint-Antoine.
      • Perpignan, France, 66046
        • Centre Hospitalier Joffre
      • Reims, France, 51092
        • Chu de Reims
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Toulouse, France, 40031
        • Hematology Dpt, Hopital Purpan
      • Tours, France, 37044
        • CHU Bretoneau
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Ile de France
      • Le Kremlin-Bicêtre, Ile de France, France, 94275
        • CHU de Bicetre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure
Survival
Response duration
Time to progression to AML
Toxicity (hematological and non-hematological)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francophone des Myelodysplasies

Collaborators

Janssen-Cilag Ltd.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

April 1, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 19, 2014

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFM-DEC-LMMC-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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