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

NCT01969942 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-05-09

No results posted yet for this study

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.

Conditions

  • Ewing Sarcoma

Interventions

BIOLOGICAL

allogeneic stem cell transplantation

DRUG

Clyclophosphamide

DRUG

Fludarabina

DRUG

Busulfan

DRUG

Melphalan

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Kenneth Lucas, M.D. · University of Louisville

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01969942 on ClinicalTrials.gov