drugset / Trial / NCT01969942

A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Relapsed or Therapy Refractory Ewing Sarcoma

NCT01969942

Phase 1 Withdrawn University of Louisville
Non-randomizedSingle-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 Ewing Sarcoma (ES). Donors will consist of either Human Leukocyte Antigen identical (HLA)or 9/10 (A, B, C, DR, DQ \[A, B, C, are Class I markers for HLA and DR and DQ are Class II markers for Matching for Transplant for Donors to match with recipient\]) matched related or unrelated donors. Specifically, we will examine: * The toxicity of allogeneic stem cell transplant (SCT) in this patient population, as related to incidence of grade 3-4 acute Graft Verse Host Disease (GVHD). * The incidence of transplant related mortality at 100 days.

Timeline

Start
2013-04
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule
Subject Clyclophosphamide Unknown
Subject FLUDARABINE Small molecule
Subject Melphalan Small molecule

Indications