drugset / Trial / NCT01464359
T-Cell Depleted Double UCB for Refractory AML
NaSingle-groupOpen-labelTreatment
Summary
This trial is proposes to build on our experience and is designed to maximize early (day 3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in vivo. The proposed platform will allow us the unique opportunity to compare in vivo function from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors requiring "education" in the recipient).
Timeline
- Start
- 2011-10
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 5e+06 unknown | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 9e+06 iu | Subcutaneous |
| Background | Allopurinol | Small molecule | — | — |
| Background | Busulfan | Small molecule | 0.8 mg/kg | Intravenous |
| Background | Busulfan | Small molecule | 1.1 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Levetiracetam | Other / unclassified | — | — |