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Completed

NCT Number: NCT01098084

Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

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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Key information

Conditions

Chronic Myelomonocytic Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHR La Source orléans, Orléans, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decitabine

Drug

20mg/m2/day, one hour intravenous infusion, every day during 5 days

Primary outcomes

  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 outcomes

  1. Response duration

  2. Time to progression to AML

  3. Survival

  4. Toxicity (hematological and non-hematological)

Sponsors and collaborators

Lead sponsor

Groupe Francophone des Myelodysplasies

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2010
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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