Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Solid Tumors, Hematologic Neoplasms

Intervention / Treatment
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* Drug: Fludarabine, Busulfan, Thymoglobulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary criterion - Hematological reconstitution and chimerism post-transplantation |  | post-transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allograft, Children, malignancy, Reduced Intensity Conditioning, Fludarabin, Busulfex, Thymoglobulin