Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
This trial is active, not recruiting.
|Conditions||ewing, soft tissue sarcoma|
|Treatment||allogeneic hemopoietic stem cell transplant|
|Sponsor||St. Orsola Hospital|
|Collaborator||S. Anna Hospital|
|Start date||June 2009|
|End date||June 2010|
|Trial size||140 participants|
|Trial identifier||NCT00998361, CE_clin.42_2009_S_sper|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
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
Transplant related mortality
time frame: 12 months after the enrollement of the first patients
Male or female participants from 1 month up to 60 years old.
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
|Official title||Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas|
|Principal investigator||Arcangelo Prete, MD, PhD, PI|
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