NCT00998361

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 20, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

October 18, 2009

Last Update Submit

October 19, 2009

Conditions

EwingSoft Tissue Sarcoma

Keywords

SarcomaallogeneicHemopoietic stem cell transplant

Outcome Measures

Primary Outcomes (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.

    12 months from the enrollement

Secondary Outcomes (1)

  • Transplant related mortality

    12 months after the enrollement of the first patients

Study Arms (1)

Stem Cell Transplant

EXPERIMENTAL

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

Interventions

Allogeneic hemopoietic stem cell transplantPROCEDURE

administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell

Also known as: CE_clin.42_2009_S_sper
Stem Cell Transplant

Eligibility Criteria

Age1 Month - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Arcangelo Prete, MD, PhD, PI

    S. Orsola-Malpighi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 20, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

October 20, 2009

Record last verified: 2009-10

Locations

IT(1)