Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2007-04-30
2009-04-30
Brief Summary
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To study acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post-transplantation To study the effectiveness of the protocol on tumor response.
To study overall survival.
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Detailed Description
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* Hematological reconstitution and chimerism post-transplantation
Secondary criteria
* Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
* Analysis of variations in post-transplantation immunological function profiles
* Median duration of response in therapy-responsive patients and median duration of stability in stabilized patients
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Fludarabine, Busulfan, Thymoglobulin
study :
* acute and/or chronic graft-versus-host reaction (incidence and severity) and immune reconstitution, post transplantation
* the effectiveness of the protocol on tumor response
* overall survival
Eligibility Criteria
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Inclusion Criteria
* Lansky score \> 60%
* Life expectancy greater than 2 months
* Diagnoses:
3- Solid tumor or hematological malignancy remaining unresponsive to the reference strategies according to French best practices in pediatrics.
4- Malignancies for which allografting is the recognized indication but is contraindicated with myeloablative conditioning.
* Usual criteria for allogeneic grafting (pre-graft profile)
* Having a HLA-identical sibling donor for HLA-A, HLA-B and HLA-DR antigens or a HLA mismatch on only one antigen, or having a 10/10 pheno-identical donor, or compatible cord blood.
* Signed informed consent
Exclusion Criteria
* In cases where the potential donor is related, sibling presenting contraindication against hematopoietic stem cell donation
* Unable to sufficiently understand the treatment and its consequences, even after explanation
20 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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CHU Clermont-Ferrand
Principal Investigators
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Paillard Catherine, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Paillard Catherine
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHU-0039
Identifier Type: -
Identifier Source: org_study_id
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