drugset / Trial / NCT01050764
Haploidentical Allogeneic Transplant With Post-transplant Infusion of Regulatory T-cells
NaSingle-groupOpen-labelTreatment
Summary
Patients with hematologic malignancies will receive myeloablative chemotherapy followed by stem cell rescue with bone marrow or hematopoietic peripheral blood stem cells collected by apheresis from a filgrastim- (G-CSF)-mobilized haploidentical related-donor, ie, hematopoietic peripheral blood stem cell transplant (HSCT).
Timeline
- Start
- 2009-06
- Primary completion
- 2012-08
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Conventional T-Cells | Cell therapy | 300000 cells/kg | — |
| Subject | Conventional T-Cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Conventional T-Cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | Conventional T-Cells | Cell therapy | 1e+07 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 100000 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 300000 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | Regulatory T cells | Cell therapy | 3e+06 cells/kg | — |
| Background | Fludarabine | Small molecule | 160 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Thiotepa | Other / unclassified | 10 mg/kg | Intravenous |
| Background | Thymoglobulin | Protein / enzyme biologic | 6 mg/kg | Intravenous |