Clinical trial NCT00042016: Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
Official title: A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic myelogenous leukemia
CML
CML-CP
Chronic phase
Decitabine
5-aza-2'deoxycytidine
Methylation
STI 571
Imatinib mesylate
Gleevec
BCR/ABL
Lead sponsor: Astex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2002-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and efficacy of decitabine in patients with Philadelphia chromosome-positive chronic myelogenous leukemia chronic phase that were previously treated with imatinib mesylate (STI 571) and became resistant/refractory or were found to be intolerant to the drug.


Eligibility criteria: Inclusion:

* Histologically confirmed diagnosis of CML chronic 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 chronic 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Escondido
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: USC/Norris Cancer Center
state: California
city: St. Louis Park
country: United States
facility: Metro-Minnesota CCOP
state: Minnesota
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Columbia
country: United States
facility: Liberty Hematology/Oncology
state: South Carolina
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References: