Clinical Trial: Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

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

Official Title: A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying the side effects of azacitidine and to see how well it works in treating patients with chronic myelomonocytic leukemia.


Detailed Summary:

OBJECTIVES:

Primary

  • To assess the safety and tolerability of azacitidine in patients with chronic myelomonocytic leukemia (CMML).
  • To assess the overall response rate in these patients.

Secondary

  • To assess the incidence of clinical remission/complete remission or partial response in these patients.
  • To assess hematological improvement in patients treated with this drug.
  • To assess the overall survival of patients treated with this drug.
  • To assess progression-free survival of patients treated with this drug.
  • To assess the time to acute myeloid leukemia (AML) transformation of CMML.
  • To assess the time to death or AML transformation of CMML.
  • To assess the biological correlates.

OUTLINE: This is a multicenter study.

Patients receive azacitidine subcutaneously on days 1-5 and 8-9. Treatment repeats every 4 weeks for at least 6 courses in the absence of loss of response/disease progression or unacceptable toxicity. Patients undergo response evaluation after 6 courses or the last course of treatment. Responders may continue azacitidine until loss of response/disease progression or unacceptable toxicity.

Some patients undergo blood, bone marrow, and buccal swab sample collection periodically for correlative studies.

After
Sponsor: University of Leeds

Current Primary Outcome:

  • Safety and tolerability
  • Overall response rate


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria
  • Hematological improvement according to IWG criteria
  • Overall survival
  • Progression-free survival
  • Time to acute myeloid leukemia (AML) transformation of CMML
  • Time to death or AML transformation of CMML
  • Biological correlates


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: November 4, 2010
Date Started: January 2010
Date Completion:
Last Updated: August 23, 2013
Last Verified: November 2010