Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Phase 2

• Conditions: Ewing; Soft Tissue Sarcoma
• Interventions: Procedure: Allogeneic hemopoietic stem cell transplant

• Registration Number: NCT00998361
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This is a perspective multicentric study for the treatment of patients aged equal or less than 60 years and submitted to an allogeneic hematopoietic stem cell transplantation from an HLA compatible related or unrelated donor because affected by resistent or refractory or relapsed after autologous stem cell transplantation Ewing Sarcoma or Soft tissues sarcoma who did not benefit from conventional therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-19
• Last Update Submitted: 2009-10-19
• Study First Posted: 2009-10-20
• Last Update Posted: 2009-10-20
• Primary Completion: 2010-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Age 0-60 years.
• Performance status according to Karnofsky score > 70%
• Normal liver function
• Normal renal function
• Normal cardiac function
• Informed consent
• Availability of an HLA compatible Donor

Exclusion Criteria

• Absence of at least one of the inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell Transplant	Allogeneic hemopoietic stem cell transplant	All the patient who are affected by refractory or resistant or relapsed Soft tissue sarcoma o Ewing sarcoma who find an HLA compatible allogeneic donor and are submitted to Stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) a 12 months from the enrollment higher than 30% for the patients submitted to allogeneic stem cell transplantation in front of the patients who received conventional chemotherapy.	12 months from the enrollement

Secondary Outcome Measures

Name	Time	Method
Transplant related mortality	12 months after the enrollement of the first patients

Trial Locations

Locations (1)

Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital; 🇮🇹 Bologna, Italy