Ewing, Soft Tissue Sarcoma
Conditions
Keywords
Sarcoma, allogeneic, Hemopoietic stem cell transplant
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.
Interventions
PROCEDUREAllogeneic hemopoietic stem cell transplant
administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell
Sponsors
S. Anna Hospital
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Transplant related mortality | 12 months after the enrollement of the first patients |
Countries
Italy
Outcome results
None listed