Clinical trial · Interventional
Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Phase II Study of Decitabine in Acute Myeloid Leukemia
NCT00492401CI-TRIAL-00022740completedPhase 2Results postedClinicalTrials.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)
This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Secondary Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Untreated Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
| DNA methylation analysis | Genetic | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: decitabine
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Other: high performance liquid chromatography
- Genetic: microarray analysis
- Genetic: RNA analysis
- Other: mass spectrometry
- Genetic: DNA methylation analysis
- Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Primary outcomes (1)
- measure
- Rate of Complete Remission
- timeFrame
- Up to 24 weeks
- description
- Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul. Complete Remission Rate (CRm + CRi)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed acute myeloid leukemia (AML) meeting 1 of the following criteria: * At least 60 years of age and not a candidate for or refused standard induction treatment * Poor risk cytogenetics * AML following antecedent hematologic disorder * Therapy-related AML * Secondary AML * No granulocytic sarcoma as sole site of disease * No active CNS disease or CNS relapse * ECOG performance status 0-2 * Life expectancy \> 6 months * Total bilirubin \< 2.0 mg/dL * Creatinine \< 2.0 mg/dL * AST and ALT \< 2.5 times upper limit of normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No NYHA class III or IV congestive heart failure * No uncontrolled infection * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed * No other uncontrolled illness including, but not limited to, any of the following: * Symptomatic congestive heart failure * Unstable angina pectoris * Serious cardiac arrhythmia * Psychiatric illness or social situations that would preclude compliance with study requirements * No active second malignancy involving the blood or marrow or likely to progress and require therapy in the next 6 months * No prior therapy for AML except emergency leukapheresis or hydroxyurea for leukocytosis * No prior azacitidine or decitabine * No prior cytarabine or other conventional chemotherapy agents for antecedent hematologic disorders * Prior myeloid growth factors, recombinant erythropoietin, thalidomide, or lenalidomide allowed * No concurrent palliative radiotherapy * No other concurrent investigational agents * No other concurrent direct anti-leukemia therapy * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (1)
- DERIVEDBlum W, Garzon R, Klisovic RB, Schwind S, Walker A, Geyer S, Liu S, Havelange V, Becker H, Schaaf L, Mickle J, Devine H, Kefauver C, Devine SM, Chan KK, Heerema NA, Bloomfield CD, Grever MR, Byrd JC, Villalona-Calero M, Croce CM, Marcucci G. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7473-8. doi: 10.1073/pnas.1002650107. Epub 2010 Apr 5. PMID 20368434