drugset / Trial / NCT01120457

First in Human Study to Determine the Safety, Tolerability and Preliminary Efficacy of an Anti-CXCR4 Antibody in Subjects With Acute Myelogenous Leukemia and Selected B-cell Cancers

NCT01120457

Phase 1 Completed 96 enrolled Bristol-Myers Squibb
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability of BMS-936564 (MDX-1338) in relapsed Acute myelogenous leukemia (AML) and other selected B-cell cancers and to determine the maximum tolerated dose (MTD) of the drug alone in relapsed/refractory AML

Timeline

Start
2010-08
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulocuplumab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Ulocuplumab Monoclonal antibody 10 mg/kg Intravenous