drugset / Trial / NCT04872595
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side effects. Participants in this study will be children and adults who have acute leukemia or myelodysplastic syndrome (MDS), and will receive a standard conditioning regimen to prepare the body for an allogeneic hematopoietic cell transplant (allo-HCT). The conditioning regimen will include r-ATG, one of two combinations of chemotherapy, and possibly total body irradiation (TBI).
Timeline
- Start
- 2021-04-30
- Primary completion
- 2027-04
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | — |
| Subject | Melphalan | Small molecule | 70 mg/m2 | — |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | — |