Clinical trial · Interventional
Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
A Phase II Study of Omacetaxine (OM) and Decitabine (DAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual-2 patients were registered Phase I and none in Phase II
Summary
Brief summary (as posted)
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decitabine | Drug | Decitabine | ALIAS |
| Omacetaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omacetaxine + Decitabine
- description
- Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle. Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle. Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.
- interventionNames
- Drug: Omacetaxine
- Drug: Decitabine
Primary outcomes (1)
- measure
- Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC)
- timeFrame
- 28 days
- description
- Safe dose defined as highest dose level with \</= 1 out of 6 patients experience a dose limiting toxicity (DLT) during first treatment cycle. DLT defined as clinically significant Grade 3 or 4 adverse event or abnormal laboratory value according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously untreated AML (\>/= 20% blasts) or AML M6. Patients with high-risk (intermediate-2 or high by IPSS or \>/= 10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. No prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy. 2. Age \>/= 70 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. 4. Adequate hepatic (serum total bilirubin \</= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or SGOT \</= 2.5 x ULN) and renal function (creatinine \</= 2.0 mg/dL). 5. Patients must be willing and able to review, understand, and provide written consent before starting therapy. 6. Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation. Exclusion Criteria: 1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure \>/= 160 systolic and \>/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure. 2. Myocardial infarction in the previous 12 weeks (from the start of treatment). 3. Active and uncontrolled disease/infection as judged by the treating physician. 4. Acute promyelocytic leukemia (APL).
References
Publications (0)
Data not yet available