drugset / Trial / NCT03476239

Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

NCT03476239

Phase 3 Completed 121 enrolled Amgen
NaSingle-groupOpen-labelTreatment

Summary

This study is being done to evaluate the rate of hematological response (complete remission/complete remission with partial hematological recovery \[CR/CRh\*\]) induced by blinatumomab in Chinese adults with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Timeline

Start
2017-10-18
Primary completion
2019-08-21
Completion
2021-04-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 28 ug Intravenous
Background Cyclophosphamide Other / unclassified 20 mg Intravenous