Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
Summary
This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Timeline
- Start
- 2019-11-19
- Primary completion
- 2027-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic CD34+-enriched and CD45RA-depleted PBSCs | Unknown | — | Intravenous |
| Subject | Busulfan | Small molecule | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Fludarabine | Small molecule | — | Intravenous |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Subject | Peripheral blood stem cells | Cell therapy | — | Intravenous |
| Subject | Thiotepa | Other / unclassified | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Sirolimus | Small molecule | — | Intravenous |
| Background | Tacrolimus | Small molecule | — | Intravenous |