Clinical Trial: Decitabine in Patients With Chronic Myelomonocytic Leukemia (CMML)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Groupe Francophone des Myelodysplasies

Current Primary Outcome: To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Groupe Francophone des Myelodysplasies

Dates:
Date Received: April 1, 2010
Date Started: November 2008
Date Completion:
Last Updated: March 19, 2014
Last Verified: March 2011