Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Primary Purpose
Ewing, Soft Tissue Sarcoma
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Allogeneic hemopoietic stem cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Ewing focused on measuring Sarcoma, allogeneic, Hemopoietic stem cell transplant
Eligibility Criteria
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
Sites / Locations
- Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stem Cell Transplant
Arm Description
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
Outcomes
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.
Secondary Outcome Measures
Transplant related mortality
Full Information
NCT ID
NCT00998361
First Posted
October 18, 2009
Last Updated
October 19, 2009
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
S. Anna Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00998361
Brief Title
Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Official Title
Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
S. Anna Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ewing, Soft Tissue Sarcoma
Keywords
Sarcoma, allogeneic, Hemopoietic stem cell transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stem Cell Transplant
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Allogeneic hemopoietic stem cell transplant
Other Intervention Name(s)
CE_clin.42_2009_S_sper
Intervention Description
administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Transplant related mortality
Time Frame
12 months after the enrollement of the first patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arcangelo Prete, MD, PhD, PI
Organizational Affiliation
S. Orsola-Malpighi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
City
Bologna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
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