drugset / Trial / NCT02707393
Allogeneic Stem Cell Transplantation for Children With CML
NaSingle-groupOpen-labelTreatment
Summary
In children and adolescents with chronic myeloid leukaemia (CML) stem cell transplantation (SCT) may be a valid alternative to the life-long treatment with tyrosinkinase inhibitors (TKI). This trial aims to evaluate the use of a reduced intensity conditioning regimen (RIC), consisting of fludarabine, melphalan and thiotepa in order to minimize transplant related mortality and toxic late effects. Strict post-transplant monitoring and reintroduction of TKI as well as donor lymphocyte infusions (DLI) in case of relevant residual disease are part of the protocol.
Timeline
- Start
- 2009-04-30
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | ATG | Unknown | — | Intravenous |
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Fludarabine | Small molecule | 40 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Intravenous |
| Background | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |
| Background | bone marrow or peripheral blood stem cells | Cell therapy | — | — |