Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine, Busulfan, Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Primary criterion - Hematological reconstitution and chimerism post-transplantation
- timeFrame
- post-transplantation
Secondary outcomes (1)
- measure
- Secondary criteria - Adverse effects, graft-related mortality at D90 and at 12 months, incidence and severity of acute and/or chronic GVH reactions
- timeFrame
- post-transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available