Solid Tumors Clinical Trial
— RICEOfficial 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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | April 2009 |
| Est. primary completion date | April 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 20 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Paillard Catherine | Clermont-Ferrand |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary criterion - Hematological reconstitution and chimerism post-transplantation | post-transplantation | Yes | |
| Secondary | Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions | post-transplantation | Yes |
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