drugset / Trial / NCT03018223
Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT
NaSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.
Timeline
- Start
- 2017-01-31
- Primary completion
- 2018-12-15
- Completion
- 2021-03-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Subject | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Intravenous |
| Subject | Sirolimus | Small molecule | 9 mg | Oral |
| Background | Busulfan | Small molecule | — | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
| Background | Fludarabine | Small molecule | 40 mg/m2 | — |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Intravenous |