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Status unknownNCT00998361Updated Oct 20, 2009

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

A Phase 2 interventional study of Allogeneic hemopoietic stem cell transplant in Ewing and Soft Tissue Sarcoma, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Status unknown at 1 site in Italy. Open to participants aged 1 Month to 60 Years. Per ClinicalTrials.gov, last updated 2009-10-20.

Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Non-randomized
Ages
1 Month to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ewing
  • Soft Tissue Sarcoma

Keywords

  • Sarcoma
  • allogeneic
  • Hemopoietic stem cell transplant
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 140 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Absence of at least one of the inclusion criteria
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (actual)

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

    Procedure: Allogeneic hemopoietic stem cell transplant

Interventions

  • ProcedureAllogeneic hemopoietic stem cell transplant

    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

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What researchers measure

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.

    Time frame: 12 months from the enrollement

Secondary outcomes

  1. Transplant related mortality

    Time frame: 12 months after the enrollement of the first patients

07

Study locations

1 site
  • Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
    Bologna, 40138, Italy
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00998361
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborators
S. Anna Hospital
First posted
Oct 20, 2009
Start date
Jun 2009
Primary completion
Jun 2010 (estimated)
Completion
Jun 2011 (estimated)
Last update
Oct 20, 2009

Study contacts

Arcangelo Prete, MD, PhD, PI
principal investigator · S. Orsola-Malpighi Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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