CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 24 enrolled
Drug / intervention
Omacetaxine Mepesuccinate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04874194
NCT04874194Phase 2Terminated
Terminated

Phase Ib/II Study of Omacetaxine and Venetoclax for Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1

M.D. Anderson Cancer Center·interventional·Posted May 5, 2021·Updated Nov 3, 2025

In Brief

A Phase 2 clinical trial evaluating Omacetaxine Mepesuccinate and Venetoclax for Hematopoietic and Lymphoid Cell Neoplasm and 6 related conditions. Terminated early, enrolled 24 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

This phase Ib/II trial best dose, possible benefits and/or side effects of omacetaxine and venetoclax in treating patients with acute myeloid leukemia or myelodysplastic syndrome that has come back (recurrent) or does not respond to treatment (refractory) and have a genetic change RUNX1. Drugs used in chemotherapy, such as omacetaxine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving omacetaxine and venetoclax may help to control the disease.

Study Details

Timeline

Phase 2TerminatedFinished
20222023202420252026
First PostedMay 5, 2021
Enrollment StartDec 17, 2021
Primary CompletionSep 16, 2024
TodayJul 1, 2026
Enrollment to primary: 2.7 yearsPosted 5.2 years ago

Interventions

Omacetaxine Mepesuccinatedrug

Given SC

Venetoclaxdrug

Given PO