Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced toxicity myeloablative" conditioning regimen in young patients (children and adolescents) with hematologic malignancies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drugs | Experimental | Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-related mortality (TRM) | Evaluation of the cumulative incidence of TRM at 12 months after transplantation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of engraftment | Incidence of engraftment defined as the first day of neutrophil (>500/μl for 3 consecutive days). Engraftment failure is defined as neutrophil <500/μl at day+42 after allo-SCT. | Day+42 |
| Evaluation of overall (OS) and disease-free survival (DFS) |
Not provided
Inclusion Criteria
Children and adolescents aged over 12 months and under 25 years
Availability of an HLA identical family donor or an HLA-matched unrelated donor (10/10 or 9/10 if the mismatch level is at HLACw for an unrelated donor) or availability of an HLA matched cord blood (5/6 or 6/6)
Informed consent signed by patients (18-25 years) and patient's legal representative, parent(s) or guardian (cf p13)
Diagnosis of a hematologic malignancy which is a candidate for allo-HSCT, but not eligible for standard or conventional myeloablative conditioning regimens because of high risk for toxicity.
Are considered as criteria of non-eligibility for standard or conventional myeloablative conditioning:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mohamad MOHTY, Professor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Besançon | France | ||||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36028757 | Derived | Rialland F, Grain A, Labopin M, Michel G, Gandemer V, Paillard C, Pochon C, Clement L, Brissot E, Jubert C, Sirvent A, Rohrlich PS, Plantaz D, Dalle JH, Mohty M. Reduced-toxicity myeloablative conditioning regimen using fludarabine and full doses of intravenous busulfan in pediatric patients not eligible for standard myeloablative conditioning regimens: Results of a multicenter prospective phase 2 trial. Bone Marrow Transplant. 2022 Nov;57(11):1698-1703. doi: 10.1038/s41409-022-01769-5. Epub 2022 Aug 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Evaluation of overall (OS) and disease-free survival (DFS) at 1 year after transplantation |
| 12 months |
| Cumulative incidence of relapse, death from disease, and non-relapse mortality (NRM) | Cumulative incidence of relapse, death from disease, and non-relapse mortality (NRM) | 12 months |
| Cumulative incidences and severity of acute and chronic Graft-versus-Host disease | Cumulative incidences and severity of acute and chronic Graft-versus-Host disease | 12 months |
| Immune Recovery (to be determined in a subgroup of patients) | Immune Recovery parameters: blood counts, bone marrow aspiration with evaluation of morphological response. | 12 months |
| Bordeaux |
| France |
| University Hospital | Clermont-Ferrand | France |
| University Hospital | Grenoble | France |
| University Hospital | Lille | France |
| University Hospital | Lyon | France |
| University Hospital | Marseille | France |
| University Hospital | Montpellier | France |
| University Hospital | Nancy | France |
| University Hospital | Nantes | France |
| University Hopsital | Paris | France |
| University Hospital | Paris | France |
| University Hospital | Rennes | France |
| University Hopsital | Rouen | France |
| University Hospital | Strasbourg | France |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D000961 | Antilymphocyte Serum |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided