drugset / Trial / NCT02472392

Study To Examine Toxicity Of Allogeneic Stem Cell Transplantation For Relapsed Or Therapy Refractory Ewings Sarcoma

NCT02472392

Phase 1 Completed 10 enrolled University of Louisville
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to examine the toxicity of using allogeneic stem cell transplantation for treatment of subjects with relapsed or refractory ES and rhabdomyosarcoma. This is a nanrandomized two-arm study is designed to determine the safety and incidence of graft versus host disease (GVHD) in patients with relapsed, refractory Ewings sarcoma receiving related and unrelated, allogeneic stem cell transplants.

Timeline

Start
2013-04
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Busulfan Small molecule 0.8 mg/kg Intravenous
Comparator Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Comparator Fludarabine Small molecule 30 mg/m2 Intravenous
Comparator Melphalan Small molecule 60 mg/m2 Intravenous
Comparator Thymoglobulin Protein / enzyme biologic 3 mg/kg Intravenous

Indications