Clinical trial · Interventional
Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
NCT01272245CI-TRIAL-00033129completedPhase 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 goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also 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 |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| Omacetaxine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omacetaxine and Cytarabine
- description
- Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
- interventionNames
- Drug: Omacetaxine
- Drug: Cytarabine
Primary outcomes (1)
- measure
- Percentage of Participants With Complete Remission (CR)
- timeFrame
- Up to 4 months
- description
- Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia
Secondary outcomes (4)
- measure
- Evaluation of CR Duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously untreated AML (\>/= 20% blasts). Patients with high-risk (intermediate-2 or high by International Prostate Symptom Score (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. 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 \>/= 60 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 serum glutamate oxaloacetate transaminase (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. 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), 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. Pregnancy. 5. Acute promyelocytic leukemia (APL). 6. Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as \>/= 1 year postmenopausal or surgically sterilized. 7. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.