drugset
drugset / Trial / NCT03434704

Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

NCT03434704 ↗

Phase 2 Completed 10 enrolled Ciceri Fabio
NaSingle-groupOpen-labelTreatment

Summary

SIR-POSA is a phase II trial of peripheral blood stem cell (PBSC) transplantation from a partially compatible family (Haplo) donor in patients with a blood tumor (myelodysplastic syndrome (MDS) and acute leukemia) treated for the prevention of primary fungal infections with posaconazole. The aim is evaluate the composite end-point graft-versus-host disease-free, relapse-free survival (GRFS) in these patients and evaluate the feasibility and efficacy of posaconazole oral tablets as primary antifungal prophylaxis.

Timeline

Start
2018-06-18
Primary completion
2019-10-13
Completion
2019-10-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule 300 mg Oral
Background 2-MERCAPTOETHANESULFONIC ACID Small molecule — —
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Mycophenolate Sodium Unknown 15 mg/kg Intravenous
Background Sirolimus Small molecule — Oral
Background Thiotepa Other / unclassified 5 mg/kg Intravenous
Background Treosulfan Small molecule 14000 mg/m2 Intravenous

Indications

acute leukemia fungal infectious disease graft versus host disease myelodysplastic syndrome