Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)

Tracking Information
First Submitted Date ICMJE	July 19, 2002
First Posted Date ICMJE	July 23, 2002
Last Update Posted Date	December 17, 2007
Study Start Date ICMJE	July 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00041990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Accelerated Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
Official Title ICMJE	A Phase II, Multicenter Study of Decitabine (5-Aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Accelerated Phase Refractory to Imatinib Mesylate (STI 571)
Brief Summary	To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia accelerated phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Chronic Myelogenous Leukemia
Intervention ICMJE	Drug: decitabine (5-aza-2'deoxycytidine)
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	40
Original Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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 </= 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
Sex/Gender	Sexes Eligible for Study: All
Ages	2 Years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00041990
Other Study ID Numbers ICMJE	DAC-013; DACO-013
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Astex Pharmaceuticals
Collaborators ICMJE	Eisai Inc.
Investigators ICMJE	Not Provided
PRS Account	Astex Pharmaceuticals
Verification Date	December 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP