drugset / Trial / NCT03018223

Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

NCT03018223

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

EvaluationDrugModalityDoseRoute
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