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Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas


Phase 2
1 Month
60 Years
Open (Enrolling)
Both
Ewing, Soft Tissue Sarcoma

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Trial Information

Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

12 months from the enrollement

Safety Issue:

Yes

Principal Investigator

Arcangelo Prete, MD, PhD, PI

Investigator Role:

Principal Investigator

Investigator Affiliation:

S. Orsola-Malpighi Hospital

Authority:

Italy: Ethics Committee

Study ID:

CE_clin.42_2009_S_sper

NCT ID:

NCT00998361

Start Date:

June 2009

Completion Date:

June 2011

Related Keywords:

  • Ewing
  • Soft Tissue Sarcoma
  • Sarcoma
  • allogeneic
  • Hemopoietic stem cell transplant
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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