Status:
UNKNOWN
Allogeneic Hematopoietic Stem Cell Transplantation
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Solid Tumors
Hematologic Neoplasms
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
Brief Summary
To assess the engraftment of hematopoietic stem cells following reduced-intensity conditioning in children presenting with solid tumors or hematological malignancy by evaluating post-transplantation c...
Detailed Description
Primary criterion * Hematological reconstitution and chimerism post-transplantation Secondary criteria * Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of ...
Eligibility Criteria
Inclusion
- Patients aged less than 20 years old
- 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
- Patient presenting rapidly-progressive malignancy
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00750126
Start Date
April 1 2007
End Date
April 1 2009
Last Update
January 19 2011
Active Locations (1)
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1
Paillard Catherine
Clermont-Ferrand, France, 63003