Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

Phase 1/2 Active not recruiting 28 enrolled University of Colorado, Denver

Non-randomizedSequentialOpen-labelTreatment

Summary

This study will treat patients with previously untreated high grade myleodysplastic syndromes (MDS) with both omacetaxine mepesuccinate and azacitidine.

Timeline

Start: 2018-09-17
Primary completion: 2025-10-07
Completion: 2027-06

Publications

Pollyea DA, Stevens BM, Abbott D, Amaya M, Gutman JA, Kent A, McMahon C, Schwartz M, Smith C, Dell-Martin J, Sohalski C, Ellis A, Haag M, Schowinsky J, Pan Z, Patel SB, Ransom M, Gillen A, Jordan CT, Pietras EM. Omacetaxine and azacitidine for untreated patients with myelodysplastic syndromes and excess blasts: a phase I/II clinical trial. EClinicalMedicine. 2025 Oct 10;89:103546. doi: 10.1016/j.eclinm.2025.103546. eCollection 2025 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	75 mg/m2	—
Subject	Omacetaxine	Unknown	0.5 mg/m2	Subcutaneous
Subject	Omacetaxine	Unknown	0.75 mg/m2	Subcutaneous
Subject	Omacetaxine	Unknown	1 mg/m2	Subcutaneous
Subject	Omacetaxine	Unknown	1.25 mg/m2	Subcutaneous

Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS

Summary

Timeline

Publications

Drugs

Indications