Solid Tumors Clinical Trial
Official title:
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.
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
- 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
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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