Phase 2
Completed N=36
Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Source: ClinicalTrials.gov NCT01272245 ↗Enrolled (actual)
36
Serious AEs
55.6%
Results posted
May 2018
Primary outcomePrimary: Percentage of Participants With Complete Remission (CR) — 44 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Remission (CR) |
44 | — |
| SECONDARY Evaluation of CR Duration |
10.6 | — |
| SECONDARY Disease-free Survival |
3.1 | — |
| SECONDARY Overall Survival |
8.1 | — |
| SECONDARY Induction Mortality |
4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
- Age >/= 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status /= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), diabetes mellitus, or congestive heart failure.
- Myocardial infarction in the previous 12 weeks (from the start of treatment).
- Active and uncontrolled disease/infection as judged by the treating physician.
- Pregnancy.
- Acute promyelocytic leukemia (APL).
- Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
- Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Data sourced from ClinicalTrials.gov (NCT01272245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.