drugset / Trial / NCT01181258

Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies

NCT01181258

Phase 2 Completed 16 enrolled Masonic Cancer Center, University of Minnesota
NaSingle-groupOpen-labelTreatment

Summary

In this study the investigators investigate a cell therapy strategy that could harness allogeneic effectors that can potentially mediate anti-lymphoma effect. The investigators have designed a novel lymphodepleting conditioning regimen followed by infusion of donor-derived natural killer (NK) cells and interleukin-2 (IL-2) for patients with refractory lymphoid malignancies.

Timeline

Start
2010-08
Primary completion
2015-09
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous
Subject Methylprednisolone Other / unclassified 1 mg/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject TROCULEUCEL Cell therapy 1.5e+07 cells/kg Intravenous
Subject TROCULEUCEL Cell therapy 8e+07 cells/kg Intravenous
Background aldesleukin Protein / enzyme biologic 5e+06 unknown Subcutaneous
Background aldesleukin Protein / enzyme biologic 9e+06 iu Subcutaneous