A Phase 2 interventional study of Fludarabine, Busulfan, Thymoglobulin in Solid Tumors and Hematologic Neoplasms, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged Up to 20 Years. Per ClinicalTrials.gov, last updated 2011-01-19.
Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment
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 chimerism and hematological reconstitution.
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.
Primary criterion
Secondary criteria
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
Primary criterion - Hematological reconstitution and chimerism post-transplantation
Time frame: 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
Time frame: post-transplantation
This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand