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

IRCCS Azienda Ospedaliero-Universitaria di Bologna140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Ewing Soft Tissue Sarcoma

Interventions

Eligibility

Sex: ALLMin age: 1 MonthMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months from the enrollement

Secondary Outcomes

Transplant related mortality

Time frame: 12 months after the enrollement of the first patients