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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
S. Anna Hospital
Information provided by:
St. Orsola Hospital

Tracking Information
First Submitted Date  ICMJE October 18, 2009
First Posted Date  ICMJE October 20, 2009
Last Update Posted Date October 20, 2009
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
Transplant related mortality [ Time Frame: 12 months after the enrollement of the first patients ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Official Title  ICMJE Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ewing
  • Soft Tissue Sarcoma
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Procedure: Allogeneic hemopoietic stem cell transplant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 19, 2009)
140
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00998361
Other Study ID Numbers  ICMJE CE_clin.42_2009_S_sper
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Augusto Cavina, S. Orsola-Malpighi Hospital
Study Sponsor  ICMJE St. Orsola Hospital
Collaborators  ICMJE S. Anna Hospital
Investigators  ICMJE
Principal Investigator: Arcangelo Prete, MD, PhD, PI S. Orsola-Malpighi Hospital
PRS Account St. Orsola Hospital
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP