drugset
drugset / Trial / NCT02029417

Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT02029417 ↗

Phase 2 Terminated 2 enrolled Roswell Park Cancer Institute National Cancer Institute (NCI) · collabTeva Pharmaceutical Industries, Ltd. · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects and how well omacetaxine mepesuccinate, cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Timeline

Start
2014-07
Primary completion
2015-11
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule — Subcutaneous
Subject Decitabine Small molecule — Intravenous
Subject Homoharringtonine Small molecule — Subcutaneous

Indications

acute erythroid leukemia acute megakaryoblastic leukemia in adult acute myeloblastic leukemia with maturation acute myeloblastic leukemia without maturation acute myeloid leukemia with 11q23 abnormalities acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) acute myeloid leukemia with minimal differentiation acute myeloid leukemia with multilineage dysplasia acute myeloid leukemia with t(8;21)(q22;q22) translocation acute myeloid leukemia, del(5q31-q32) acute myeloid leukemia, t(16;16)(p13.1;q22) acute myelomonocytic leukemia M4 adult acute monocytic leukemia