Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
This international study (ALL SCTped FORUM) looks at the best way to prepare children and teenagers with acute lymphoblastic leukaemia for a stem cell transplant from a donor. It compares total-body irradiation with chemotherapy-only conditioning, and different donor types, to find the safest and most effective approach.
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.
The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.
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Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to the growing organism and include severe organ dysfunction/failure due to toxicity. Although transplant associated mortality was reduced after HSCT in the last decade due to better HLA matching, infection prevention and control, the burden of late complications is still a matter of concern. Growth retardation, hormonal dysfunction, sterility and the risk of secondary cancer are the late consequences of TBI in children. However, so far no prospective study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen before HSCT. The reason for that is manifold: only a minority of children with ALL qualifies for allogeneic HSCT as most patients are cured with sole modern chemotherapy approaches. Those with dismal prognosis are treated in HSCT centres offering a care to patients with different diseases. Therefore it is nearly impossible to answer the complex outcome questions in single centres or even in single countries. International cooperation is essential to allow prospective investigation within comparable patient cohorts.
The trial was initiated as a prospective, randomised, global study to investigate whether chemotherapy based conditioning could replace TBI in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It was registered and approved as a prospective, randomized, cont...
- Acute Lymphoblastic Leukaemia
- VP16
- TBI
- Thiotepa
- Treosulfan
- Fludarabine
- Busulfan
- ATG Thymoglobulin
- Cyclophosphamide
- Grafalon
- Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
- Event free survival (EFS) Stratum 2 (mismatched donor transplantation) — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
- Overall Survival (OS), Stratum 1b: MSD/MD without randomisation — first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Criteria are written for physicians. Do not rule yourself out: send your reports and the study team will check.
- Acıbadem Atakent Hospital Pediatric Stem Cell Transplantation Unit, IstanbulActive, closed to enrolment
Also running at 118 other sites in 31 countries.
Source: ClinicalTrials.gov NCT01949129 · last updated 2026-09-04 · View registry record ↗