drugset / Trial / NCT01030536

Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)

NCT01030536

Phase 1/2 Completed 23 enrolled MedImmune LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], mantle cell lymphoma \[MCL\]) or CLL.

Timeline

Start
2010-02-15
Primary completion
2013-03-04
Completion
2013-03-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxetumomab Pasudotox Protein / enzyme biologic 20 ug/kg Intravenous
Subject Moxetumomab Pasudotox Protein / enzyme biologic 30 ug/kg Intravenous
Subject Moxetumomab Pasudotox Protein / enzyme biologic 40 ug/kg Intravenous
Subject Moxetumomab Pasudotox Protein / enzyme biologic 50 ug/kg Intravenous
Subject Moxetumomab Pasudotox Protein / enzyme biologic 60 ug/kg Intravenous