Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01235117
First received: November 4, 2010
Last updated: August 23, 2013
Last verified: November 2010

November 4, 2010
August 23, 2013
January 2010
December 2012   (final data collection date for primary outcome measure)
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Overall response rate [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01235117 on ClinicalTrials.gov Archive Site
  • Incidence of clinical remission/complete remission or partial response according to International Working Group (IWG) criteria [ Designated as safety issue: No ]
  • Hematological improvement according to IWG criteria [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to acute myeloid leukemia (AML) transformation of CMML [ Designated as safety issue: No ]
  • Time to death or AML transformation of CMML [ Designated as safety issue: No ]
  • Biological correlates [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Azacitidine in Treating Patients With Chronic Myelomonocytic Leukemia
A Phase 2 Study of Azacitidine in Chronic Myelomonocytic Leukemia (CMML)

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.

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 completion of study treatment, patients are followed up for 1 month.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

Interventional
Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Leukemia
  • Drug: azacitidine
  • Other: laboratory biomarker analysis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2013
December 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • All chronic myelomonocytic leukemia (CMML)-2 patients
    • CMML-1 patients meeting any of the following criteria:

      • Symptomatic bone marrow failure/myeloproliferation defined as any of the following:

        • Red cell transfusion dependence and pre-transfusion hemoglobin < 9.0 g/dL
        • Symptomatic anemia (hemoglobin < 11.5 g/dL)
        • Thrombocytopenia (platelet count < 50 x 10^9/L)
        • Symptomatic bleeding due to platelet functional defect or disseminated intravascular coagulation (DIC)/fibrinolysis
        • White cell count (WCC) > 50 x 10^9/L
      • Düsseldorf Score of intermediate or high risk for proliferative CMML-1 (i.e., WCC > 12 x 10^9/L)
      • International Prognostic Scoring System (IPSS) score of intermediate-2 or high risk for non-proliferative CMML-1 (i.e., WCC < 12 x 10^9/L)
      • Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within the past 6 months)
      • Symptomatic splenomegaly
      • Symptomatic extramedullary involvement (e.g. skin infiltration or serous effusions)
  • No CMML with eosinophilia and 5q33 abnormality

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • Creatinine ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative urine pregnancy test
  • Fertile patients must use at least 2 forms of effective contraception during study and for 3 months after completion of study therapy
  • No other active malignant disease including basal cell or squamous cell carcinoma of the skin
  • No known HIV or infectious hepatitis B or hepatitis C
  • No active infection
  • No known hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

  • At least 28 days since other prior experimental drug or therapy
  • No prior chemotherapy for this disease except hydroxycarbamide
  • No other concurrent anticancer or investigational agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01235117
CDR0000688119, CTRU-CMML-201, ISRCTN-21428905, EUDRACT-2008-006349-23, LEEDS-HM08/8540, EU-21082
Not Provided
Not Provided
University of Leeds
Not Provided
Principal Investigator: David T. Bowen, MD Leeds Cancer Centre at St. James's University Hospital
National Cancer Institute (NCI)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP