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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ewing Soft Tissue Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Allogeneic hemopoietic stem cell transplant

Intervention Type PROCEDURE

administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Interventions

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Allogeneic hemopoietic stem cell transplant

administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Intervention Type PROCEDURE

Other Intervention Names

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CE_clin.42_2009_S_sper

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No