Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation
Summary
This pilot phase II trial studies how well a new reduced intensity conditioning regimen that includes haploidentical donor NK cells followed by the infusion of selectively T-cell depleted progenitor cell grafts work in treating younger patients with hematologic malignancies that have returned after or did not respond to treatment with a prior transplant. Giving chemotherapy and natural killer cells before a donor progenitor cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (progenitor cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's cells. When the healthy progenitor cells from a related donor are infused into the patient they make red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing specific T cells from the donor cells before the transplant may prevent this.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-04
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD45RA-depleted HPC transplant | Cell therapy | — | Intravenous |
| Subject | T-cell depleted HPC transplant | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | G-CSF | Unknown | — | Intravenous |
| Background | Melphalan | Small molecule | — | Intravenous |
| Background | Natural Killer Cell Therapy | Cell therapy | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Thiotepa | Other / unclassified | — | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | — | Subcutaneous |