CD34+ Enriched Transplants From HLA-Compatible Patients With Hematologic Malignancies
Summary
This is a Phase II trial testing disease-specific myeloablative conditioning regimens for preparatory cytoreduction of patients receiving allogeneic HLA-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells (PBSC) depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system. The CliniMACS Fractionation system is a method that positively selects CD34+ progenitor cells from PBSC by immunoadsorption of cells binding on anti CD34 monoclonal antibody to paramagnetic beads, which can then be isolated by passage through a magnetized column and released by agitation of beads. Two conditioning regimens have been used successfully with an alternative similar system, isolex, which is no longer being manufactured.
Timeline
- Start
- 2022-09
- Primary completion
- 2030-03-01
- Completion
- 2030-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.8 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Melphalan | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |