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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by St. Orsola Hospital.
Recruitment status was:  Active, not recruiting
S. Anna Hospital
Information provided by:
St. Orsola Hospital Identifier:
First received: October 18, 2009
Last updated: October 19, 2009
Last verified: October 2009
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.

Condition Intervention Phase
Ewing Soft Tissue Sarcoma Procedure: Allogeneic hemopoietic stem cell transplant Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas

Resource links provided by NLM:

Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Transplant related mortality [ Time Frame: 12 months after the enrollement of the first patients ]

Enrollment: 140
Study Start Date: June 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Procedure: 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
Other Name: CE_clin.42_2009_S_sper


Ages Eligible for Study:   1 Month to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00998361

Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital
S. Anna Hospital
Principal Investigator: Arcangelo Prete, MD, PhD, PI S. Orsola-Malpighi Hospital
  More Information

Responsible Party: Dr Augusto Cavina, S. Orsola-Malpighi Hospital Identifier: NCT00998361     History of Changes
Other Study ID Numbers: CE_clin.42_2009_S_sper
Study First Received: October 18, 2009
Last Updated: October 19, 2009

Keywords provided by St. Orsola Hospital:
Hemopoietic stem cell transplant

Additional relevant MeSH terms:
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue processed this record on September 21, 2017