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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998361
Recruitment Status : Unknown
Verified October 2009 by St. Orsola Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2009
Last Update Posted : October 20, 2009
S. Anna Hospital
Information provided by:
St. Orsola Hospital

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.

Condition or disease Intervention/treatment Phase
Ewing Soft Tissue Sarcoma Procedure: Allogeneic hemopoietic stem cell transplant Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Transplant related mortality [ Time Frame: 12 months after the enrollement of the first patients ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998361

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Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
St. Orsola Hospital
S. Anna Hospital
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Principal Investigator: Arcangelo Prete, MD, PhD, PI S. Orsola-Malpighi Hospital
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Responsible Party: Dr Augusto Cavina, S. Orsola-Malpighi Hospital Identifier: NCT00998361    
Other Study ID Numbers: CE_clin.42_2009_S_sper
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: October 2009
Keywords provided by St. Orsola Hospital:
Hemopoietic stem cell transplant
Additional relevant MeSH terms:
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Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue