EwingPhase 2NCT00998361
Hematopoietic Stem Cell Transplantation From Human Leukocyte Antigen (HLA) Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
A Phase 2 study testing Allogeneic hemopoietic stem cell transplant in people with Ewing and Soft Tissue Sarcoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 60 years
- Conditions the study is for
- Ewing, Soft Tissue Sarcoma
- What is being tested?
- Allogeneic hemopoietic stem cell transplant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Absence of at least one of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site
Pediatric Oncology and Hematology Department, S. Orsola-Malpighi Hospital
Bologna, 40138
About this study
Official title: Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
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.
- Conditions
- Ewing, Soft Tissue Sarcoma
- Being tested
- Allogeneic hemopoietic stem cell transplant
- Keywords
- Sarcoma, allogeneic, Hemopoietic stem cell transplant
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic hemopoietic stem cell transplantProcedure or surgery
Also called CE_clin.42_2009_S_sper
administration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Allogeneic hemopoietic stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from the enrollement
Secondary outcomes (1)
Transplant related mortality
Measured: 12 months after the enrollement of the first patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EwingStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- S. Anna Hospital
- Investigators
- Arcangelo Prete, MD, PhD, PI, Principal investigator, S. Orsola-Malpighi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998361
- Sponsor's protocol ID
- CE_clin.42_2009_S_sper
- Status last verified
- Oct 2009
- First submitted
- 18 Oct 2009
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematopoietic Stem Cell Transplantation From HLA Compatible Donor in Ewing Sarcomas and Soft Tissues Sarcomas
- ClinicalTrials.gov ID
- NCT00998361
- Acronym / sponsor ID
- CE_clin.42_2009_S_sper
- Conditions
- Ewing, Soft Tissue Sarcoma
- Keywords
- Sarcoma, allogeneic, Hemopoietic stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- S. Anna Hospital
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Transplant | Experimental | Procedure: Allogeneic hemopoietic stem cell transplantAll 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 |
Who may qualify
- Ages
- 1 month to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 0-60 years.
- Performance status according to Karnofsky score > 70%
- Normal liver function
- Normal renal function
- Normal cardiac function
Key exclusion criteria (1 listed)
- Absence of at least one of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic hemopoietic stem cell transplantAlso: CE_clin.42_2009_S_speradministration of 15 mg/kg of thiotepa + 140 mg/sqm of melphalan followed by infusion of allogeneic hemopoietic stem cell | Procedure or surgery | Stem Cell Transplant |
Primary outcome
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
1 secondary outcome
Transplant related mortality
Time frame: 12 months after the enrollement of the first patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
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Combination Immunotherapy Targeting Sarcomas
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International Phase I Trial of Dinutuximab Beta With VDC/IE in GD2-Positive Ewing Sarkoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arcangelo Prete, MD, PhD, PI principal investigator
S. Orsola-Malpighi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic hemopoietic stem cell transplant in people with Ewing and Soft Tissue Sarcoma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2009.