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Omacetaxine in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (HMA) Failure
Phase 2 trial testing Omacetaxine in Leukemia in 48 participants. Completed in 14 April 2020.
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 18 May 2015 |
| Primary completion | 14 April 2020 |
| Estimated completion | 14 April 2020 |
| Sites | 1 location across United States |
M.D. Anderson Cancer Center — full company profile →
18 and older, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival defined as the time from treatment start to the time of death. Overall survival continuously monitored using the Bayesian method.
| Group | Value | 95% CI |
|---|---|---|
| Omacetaxine | 7.5 | 0.1 – 30 |
Response is Complete Response (CR) + Partial Response (PR) + Hematologic Improvement (HI). CR is the normalization of the peripheral blood and bone marrow with \</= 5% bone marrow blasts, a peripheral blood granulocyte count \>/= (1.0x10\^9/L, and a platelet count \>/= 100x10\^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. HI meets all of the criteria for CR except for platelet recovery to \>/=100x10\^9L.
| Group | Value | 95% CI |
|---|---|---|
| Omacetaxine | 16 |
Time frame: Up to 4 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Omacetaxine |
|---|---|---|
| Neutropenic Fever | Blood and lymphatic system disorders | — |
| Death | General disorders | — |
| Pneumonia | Infections and infestations | — |
| Fever | General disorders | — |
| Cellulitis | Infections and infestations | — |
| Lung Infection | Infections and infestations | — |
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Hypotension | Vascular disorders | — |
| Sepsis | Infections and infestations | — |
| Spasticity (Severe Muscle Spasm) | Musculoskeletal and connective tissue disorders | — |
| Upper Gastrointestianl Hemorrhage | Gastrointestinal disorders | — |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | — |
| Atrial Fibrillation | Cardiac disorders | — |
| Bacteremia Infection | Infections and infestations | — |
| Cardiac Ischemia | Cardiac disorders | — |
| Chest Pain | General disorders | — |
| Congestive Heart Failure | Cardiac disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Fatigue | General disorders | — |
| Graft Versus Host Disease | General disorders | — |
| Hip Fracture | Injury, poisoning and procedural complications | — |
| Left Shoulder Pain | General disorders | — |
| Oral Mucositis | Gastrointestinal disorders | — |
| Reaction | System | Omacetaxine |
|---|---|---|
| Fatigue | General disorders | — |
| Nausea/Vomiting | Gastrointestinal disorders | — |
| Infection | Infections and infestations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Edema | General disorders | — |
| Dizziness | Nervous system disorders | — |
| Forgetfulness | Nervous system disorders | — |
| Mouth Sores | Gastrointestinal disorders | — |
| Neutropenic Fever | Blood and lymphatic system disorders | — |
| Hemorrhage | General disorders | — |
Most-reported serious reactions: Neutropenic Fever, Death, Pneumonia, Fever, Cellulitis, Lung Infection, Shortness of Breath, Fall.
Data from ClinicalTrials.gov NCT02159872 adverse events section.
The goal of this clinical research study is learn if omacetaxine can help to control myelodysplastic syndrome (MDS). The safety of this drug will also be studied. This is an investigational study. Omacetaxine is FDA approved and commercially available for the treatment of chronic myelogenous leukemia (CML). It is investigational to use omacetaxine in patients with MDS. The study doctor can explain how the study drug is designed to work. Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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