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

• ClinicalTrials.gov Identifier: NCT00998361
• Recruitment Status: Unknown
• First Posted: October 20, 2009
• Last Update Posted: October 20, 2009
• Sponsor: St. Orsola Hospital
• Collaborator: S. Anna Hospital
• Information provided by: St. Orsola Hospital

Tracking Information

• First Submitted Date: October 18, 2009
• First Posted Date: October 20, 2009
• Last Update Posted Date: October 20, 2009
• Study Start Date: June 2009
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: October 19, 2009): Transplant related mortality [ Time Frame: 12 months after the enrollement of the first patients ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Ewing
• Soft Tissue Sarcoma

Intervention

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

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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 19, 2009): 140
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: June 2011
• Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 60 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT00998361
• Other Study ID Numbers: CE_clin.42_2009_S_sper
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr Augusto Cavina, S. Orsola-Malpighi Hospital
• Study Sponsor: St. Orsola Hospital
• Collaborators: S. Anna Hospital

Investigators

• Principal Investigator: Arcangelo Prete, MD, PhD, PI; S. Orsola-Malpighi Hospital

• PRS Account: St. Orsola Hospital
• Verification Date: October 2009