drugset / Trial / NCT02758223
Prophylactic Application of Donor-derived TCM After Allogeneic HSCT
NaSingle-groupOpen-labelTreatment
Summary
PACT is a non-randomized multicentre phase I/II study to evaluate the feasibility and safety of the prophylactic administration of donor derived TCM. Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are planned to undergo a HLA -matched (9/10 or 10/10) allogeneic hematopoietic stem cell transplantation and who are either 50+ years old or have a high comorbidity score are included according to criteria as described below. TCM will be applied in escalating doses to a maximum of 30 patients who have received T cell depleted Human leukocyte antigen (HLA)-matched alloHSCT grafts and qualify for TCM transfer.
Timeline
- Start
- 2016-04
- Primary completion
- 2021-05
- Completion
- 2021-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TCM allogeneic humane central memory T cells | Cell therapy | 650000 cells/kg | Intravenous |