Phase II trial of decitabine in patients with chronic myelogenous leukemia blast phase who are refractory to imatinib mesylate
(Gleevec)
This study is currently recruiting patients.
Sponsored by: |
SuperGen |
Information provided by: |
SuperGen |
Purpose
To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia
blastic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found
to be intolerant to the drug.
Condition
|
Treatment or Intervention |
Phase |
Chronic Myelogenous Leukemia
|
Drug: decitabine (5-aza-2'deoxycytidine)
|
Phase II
|
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A phase II, multicenter study of decitabine (5-aza-2’deoxycytidine) in chronic myelogenous leukemia blast phase refractory
to imatinib mesylate (STI 571)
Further Study Details:
Expected Total Enrollment:
40
Study start: July 2002
Eligibility
Ages Eligible for Study:
2 Years and above,
Genders Eligible for Study:
Both
Inclusion:
- Histologically confirmed diagnosis of CML blast 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 blast phase with the exception of hydroxyurea
- Age >/= 2 years
- Bilirubin </= 3 x the upper limit of normal (ULN), SGOT and SGPT </= 3 x ULN, except </= 5 x ULN in leukemic involvement of
the liver, serum creatinine </= 2 x ULN
- 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
Location
and Contact
Information
Jocelyn Rojas
925-560-0100
Ext. 424
Emel Bayar, MD
925-560-0100
Ext. 404
Texas University of Texas MD Anderson Cancer Center, Houston,
Texas,
77030,
United States; Recruiting
Jean-Pierre Issa, MD, Principal Investigator
More Information
Study ID Numbers:
SGI-DAC-012; DAC-012
Record last reviewed:
July 2002
Record first received:
July 19, 2002
ClinicalTrials.gov Identifier:
NCT00042003Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10