drugset / Trial / NCT01370213
NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
Timeline
- Start
- 2011-09
- Primary completion
- 2016-04
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD34+ selected peripheral blood stem cell graft | Unknown | 5e+06 cells/kg | — |
| Subject | Donor TCR α/β-depleted Graft/ATG | Unknown | 5e+06 cells/kg | — |
| Subject | TROCULEUCEL | Cell therapy | — | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 2.5 mg/kg | — |
| Background | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 3 mg/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Background | Fludarabine | Small molecule | 40 mg/m2 | — |
| Background | aldesleukin | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |