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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00042003
Enrollment
40
Registered
2002-07-23
Start date
2002-07-31
Completion date
Unknown
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myelogenous Leukemia

Keywords

Chronic myelogenous leukemia, CML, CML-BP, Blast phase, Decitabine, 5-aza-2'deoxycytidine, Methylation, STI 571, Imatinib mesylate, Gleevec, BCR/ABL

Brief summary

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.

Interventions

Sponsors

Eisai Inc.
CollaboratorINDUSTRY
Astex Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026