Clinical trial · Interventional
Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Phase I Study of 5-Aza-2'-Deoxycytidine (Decitabine) as a Biologic Modifier of Retinoid Responsive Genes in Patients With High-Risk Myelodysplastic Syndromes and Acute Myelogenous Leukemia (De-novo, Relapsed or Secondary)
NCT00049582CI-TRIAL-00012297terminatedPhase 1ClinicalTrials.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 I trial is studying the side effects and best dose of decitabine in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Conditions
Conditions (13)
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 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 |
| Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative | Atypical Chronic Myeloid Leukemia | ALIAS | 0.90 |
| de Novo Myelodysplastic Syndromes | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable | Myelodysplastic/Myeloproliferative Neoplasm, Not Otherwise Specified |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| decitabine | Drug | Decitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (decitabine)
- description
- Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- interventionNames
- Drug: decitabine
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) of decitabine, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
- timeFrame
- Up to day 28
Secondary outcomes (4)
- measure
- Minimal effective dose of decitabine that will lead to demethylation of deoxyribonucleic acid (DNA) with tolerable toxicity as assessed by RXR gene
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* One of the following diagnoses:
* High-risk myelodysplastic syndromes (MDS)
* Acute myeloid leukemia (AML)
* De novo, secondary, or relapsed disease
* Any number of prior regimens for primary or relapsed disease
* Ineligible for or refuses aggressive management
* Measurable disease, defined as:
* More than 5% blasts in bone marrow of patients with MDS
* More than 30% blasts in bone marrow of patients with AML
* Involvement of cerebrospinal fluid allowed
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* See Disease Characteristics
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* AST and/or ALT no greater than 1.25 times ULN
* Creatinine less than 1.7 mg/dL
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No ongoing or active infection
* No other uncontrolled illness that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* No prior allergic reactions to compounds of similar chemical or biological composition to decitabine
* No other active malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 4 weeks since prior biologic therapy (e.g., interferon, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], thrombopoietin, or epoetin alfa)
* No concurrent hematopoietic growth factors (GM-CSF, thrombopoietin, or epoetin alfa)
* No concurrent prophylactic G-CSF
* Prior intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement
* At least 4 weeks since prior chemotherapy (except low-dose chemotherapy administered to maintain WBC counts) (6 weeks for nitrosoureas or mitomycin) and recovered
* At least 24 hours since prior hydroxyurea
* Concurrent intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement
* No prior radiotherapy greater than 3,000 cGy to marrow-producing areas
* At least 4 weeks since prior radiotherapy and recovered
* Prior investigational therapy allowed
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.