NCT00750126

Allogeneic Hematopoietic Stem Cell Transplantation

Feasibility Study on Allogeneic Hematopoietic Stem Cell Transplantation Following Fludarabine-Busulfan-ALS-based Reduced-intensity Conditioning in Children With Hematological Malignancy or Solid Tumor Not Responding to Standard Therapy or for Which the Indication for Allograft is Maintained But Cannot be Carried Out Due to the Toxicity Involved in Myeloablative Conditioning.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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.

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 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

• Solid Tumors
• Hematologic Neoplasms

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-09-10
• Last updated: 2011-01-19

Locations

1 site across 1 country: France