drugset / Trial / NCT01639456
CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploid Donor Natural Killer Cell Treatment in Older AML in First Complete Remission
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a phase II trial designed to test the safety and efficacy (disease free survival \[DFS\]) of related donor HLA-haploidentical NK-cell based therapy for the treatment of acute myelogenous leukemia (AML). The natural killer (NK) cell product will be given to patients 60 years and older who are in a first complete remission after 1 or 2 courses of standard AML induction. After a preparative regimen of cyclophosphamide and fludarabine, patients will receive a single infusion of either CD3-/CD19- NK cells or CD3-/CD56+ NK cells followed by a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion.
Timeline
- Start
- 2013-10
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD3-/CD19- natural killer cells | Cell therapy | — | — |
| Subject | TROCULEUCEL | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |