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A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)


Phase 2
2 Years
N/A
Not Enrolling
Both
Chronic Myelogenous Leukemia

Thank you

Trial Information

A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)

Inclusion Criteria


Inclusion:

- Histologically confirmed diagnosis of CML accelerated phase

- Ph chromosome-positive

- Previous treatment with imatinib mesylate resulting in:

i) Hematologic Resistance / Hematologic Refractory: Based on a physician's
(documented) decision to discontinue imatinib mesylate treatment due to failure of
continued benefit or no benefit to the patient, ii) Imatinib Mesylate Intolerance:
any toxicity resulting in a physician's (documented) decision to discontinue imatinib
mesylate treatment.

- Patients must have recovered from the side effects of previous CML therapy for
accelerated phase with the exception of hydroxyurea

- Age >/= 2 years

- Bilirubin
- WHO performance status 0-3

- A negative serum hCG pregnancy test in patients of childbearing potential

- Able to give signed informed consent directly or through a parent or guardian for
minors

Exclusion:

- Leukemic involvement of the central nervous system

- Active malignancy other than CML or non-melanoma cancer of the skin

- Previous treatment for CML with another investigational agent within 28 days of study
entry

- At study entry, patients who were treated with: imatinib mesylate within the past 48
hours; interferon-alpha within the past 48 hours; homoharringtonine within the past
14 days; low-dose cytosine arabinoside within 7 days, moderate dose within 14 days,
or high dose within 28 days; etoposide, anthracyclines, or mitoxantrone within 21
days; busulfan within the past six weeks

- Patients who had received hematopoietic stem cell transplantation within 6 weeks of
Day 1 decitabine therapy

- Patients with Grade 3/4 cardiac disease or any other serious concurrent medical
condition.

- Patients who are pregnant or nursing. All patients of childbearing potential must
practice effective methods of contraception while on study.

- Patients with mental illness or other condition precluding their ability to give
informed consent or to comply with study requirements

- Patients with systemic, uncontrolled infections

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

DAC-013

NCT ID:

NCT00041990

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Chronic myelogenous leukemia
  • CML
  • CML-AP
  • Accelerated phase
  • Decitabine
  • 5-aza-2'deoxycytidine
  • Methylation
  • STI 571
  • Imatinib mesylate
  • Gleevec
  • BCR/ABL
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

New York Medical CollegeValhalla, New York  10595
Scripps ClinicLa Jolla, California  92037
City of Hope Medical CenterDuarte, California  91010
University of Texas MD Anderson Cancer CenterHouston, Texas  77030
USC/Norris Cancer CenterLos Angeles, California  
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Liberty Hematology/OncologyColumbia, South Carolina