drugset
drugset / Trial / NCT00895934

Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

NCT00895934 ↗

Phase 1/2 Completed 52 enrolled National Cancer Institute (NCI)
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs increase the effect of GO against leukemia cells in the test tube, but we don't know yet whether they also increase the anti-leukemia effect of GO in people.

Timeline

Start
2009-05
Primary completion
2013-07
Completion
2013-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Intravenous
Subject Gemtuzumab Ozogamicin Monoclonal antibody 3 mg/m2 Intravenous
Subject Vorinostat Small molecule 400 mg —

Indications

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 t(8;21)(q22;q22) translocation acute myelomonocytic leukemia M4 adult acute monocytic leukemia erythroleukemia