Clinical trial · Interventional
Trial of Decitabine in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
NCT00760084CI-TRIAL-00005331completedPhase 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)
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
- interventionNames
- Drug: Decitabine
Primary outcomes (1)
- measure
- The Number of Subjects With Adverse Events
- timeFrame
- 3 months
- description
- Generate safety information when patients were also taking concomitant medications and/or therapies without trial restrictions when decitabine was administered at a dose of 20 milligrams per meter squared (mg/m\^2) over a 1-hour intravenous (IV) infusion for 5 consecutive days every 4 weeks in patients with MDS (\< 30% blasts) or AML (\> 30% blasts).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must sign an Institutional Review Board (IRB) -approved informed consent form, indicating his/her awareness of the investigational nature of decitabine and its potential hazards prior to initiation of any study-specific procedures or treatment. 2. Must have had one of the following: MDS (de novo or secondary) fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with WBC \<12,000/μL) AND an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry OR AML (≥ 30 % bone marrow blasts), except M3 or acute promyelocytic leukemia. 3. Must be age 18 years or older. 4. Must have completed participation per protocol in the MGI PHARMA DACO-018 decitabine trial. 5. Must enroll in this trial no more than 8 weeks after discontinuation from the MGI PHARMA DACO-018 trial. 6. Must have recovered from all toxic effects of all prior therapy. Exclusion Criteria: 1. Must not have any other active malignancy, other than basal or squamous cell skin carcinoma. 2. Must not have received in the period after discontinuation from DACO-018 and enrollment into this trial any other chemotherapy agent, including investigational agents, for their disease. 3. Must not have evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial, at the discretion of the principal investigator. 4. Must not be pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.