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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Unknown; Phase 2

Conditions: Soft Tissue Sarcoma; Ewing

Treatments: Procedure: Allogeneic hemopoietic stem cell transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00998361

CE_clin.42_2009_S_sper

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 1 month to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Stem Cell Transplant

Experimental group

Description:

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

Treatment:

Procedure: Allogeneic hemopoietic stem cell transplant