drugset / Trial / NCT01181258
Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |