Clinical trial · Interventional
Phase II Trial of Decitabine in Patients With Chronic Myelogenous Leukemia Chronic Phase Who Are Refractory to Imatinib Mesylate (Gleevec)
A Phase II, Multicenter Study of Decitabine (5-aza-2'Deoxycytidine) in Chronic Myelogenous Leukemia Chronic Phase Refractory to Imatinib Mesylate (STI 571)
NCT00042016CI-TRIAL-00002697completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine (5-aza-2'deoxycytidine) | Drug | Decitabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
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