drugset / Trial / NCT01471782

Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

NCT01471782

Phase 1/2 Completed 93 enrolled Amgen Research (Munich) GmbH
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the dose of the bispecific T cell engager blinatumomab (MT103) in pediatric and adolescent patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and to assess whether this dose of blinatumomab is effective.

Timeline

Start
2012-01
Primary completion
2014-08
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 5 ug/m2 Intravenous
Subject Blinatumomab Monoclonal antibody 15 ug/m2 Intravenous
Subject Blinatumomab Monoclonal antibody 30 ug/m2 Intravenous