NCT01949129Recruiting
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Summary
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.
Inclusion criteria
Patients with ALL (except for patients with B-ALL) who fulfil the following criteria: • age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years • indication for allogeneic HSCT • complete remission (CR) before HSCT • written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form" • no pregnancy • no secondary malignancy • no previous HSCT • HSCT is performed in a study participating centre
Exclusion criteria
• patients who do not fulfil the inclusion criteria • Non Hodgkin-Lymphoma • the whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian • no consent is given for saving and propagation of anonymous medical data for study reasons • severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) • Karnofsky / Lansky score \< 50% • subjects unwilling or unable to comply with the study procedures
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 2 · Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, Argentina, Australia, Belarus, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Finland, Greece, Hungary, Israel, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Turkey (Türkiye)
- Sponsor
- St. Anna Kinderkrebsforschung(Other)
- Protocol no.
- ALL SCTped FORUM 2012
- Conditions
- Acute Lymphoblastic Leukaemia
- Interventions
- Drug, Radiation
Treatments studied
- VP16
- TBI
- Thiotepa
- Treosulfan
- Fludarabine
- Busulfan
- ATG Thymoglobulin
- Cyclophosphamide
- Grafalon
Collaborators
ALL SCTped Forum, European Society for Blood and Marrow Transplantation, ALL-BFM Study Group, Assistance Publique - Hôpitaux de Paris, Dutch Childhood Oncology Group, Swiss Pediatric Oncology Group, Australian & New Zealand Children's Haematology/Oncology Group
Locations · 34
- Basel, SwitzerlandUniversitäts-Kinderspital beider Basel (UKBB)Recruiting at this site
- Geneva, SwitzerlandHUG Hôpitaux Universitaire de GenèveRecruiting at this site
- Zurich, SwitzerlandUniversitäts-Kinderspital ZurichRecruiting at this site
- Graz, AustriaUniversitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-OnkologieRecruiting at this site
- Innsbruck, AustriaUniversitätsklinik für Kinder- und JugendheilkundeRecruiting at this site
- Vienna, AustriaSt. Anna Children's Hospital, Vienna, AustriaRecruiting at this site
- Buenos Aires, ArgentinaHospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABARecruiting at this site
- La Plata, ArgentinaHospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant UnitRecruiting at this site
- Brussels, BelgiumHôpital Universitaire des Enfants Reine Fabiola (HUDERF)Recruiting at this site
- Brussels, BelgiumCliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatriqueRecruiting at this site
- Ghent, BelgiumUniversity Hospital Gent Pediatrische hemato-oncologieRecruiting at this site
- Leuven, BelgiumUniversity Hospitals Leuven Kinderhemato-oncologieRecruiting at this site
- Liège, BelgiumCentre Hospitalier Universitaire de Liège Domaine Universitaire du Sart TilmanRecruiting at this site
- Santiago, ChileHospital Dr Luis Calvo MackennaRecruiting at this site
- Zagreb, CroatiaDepartment of Pediatrics, UHC ZagrebRecruiting at this site
- Prague, CzechiaDepartment of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles UniversityRecruiting at this site
- Copenhagen, DenmarkPaediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, RigshospitaletRecruiting at this site
- Athens, GreeceSaint Sophia Children's Hospital BMT UnitRecruiting at this site
- Budapest, HungaryNational Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation UnitRecruiting at this site
- Kuala Lumpur, MalaysiaUniversity of Malaya, Department of PaediatricsRecruiting at this site
- Mexico City, MexicoInstituto Nacional de PeditriaRecruiting at this site
- Utrecht, NetherlandsPrincess Máxima Center for Pediatric OncologyRecruiting at this site
- Oslo, NorwayOslo University Hospital RikshospitaletRecruiting at this site
- Riyadh, Saudi ArabiaKing Abdullah specialists children hospitalRecruiting at this site
- Bratislava, SlovakiaUniversity Children's HospitalRecruiting at this site
- Ljubljana, SloveniaUniversity childrens' hospital, UMCLRecruiting at this site
- Barcelona, SpainHospital Santa Creu i Sant PauRecruiting at this site
- Barcelona, SpainHospital Vall d'HebronRecruiting at this site
- Murcia, SpainHospital Virgen de la ArrixacaRecruiting at this site
- Oviedo, SpainHospital Universitario Central de AsturiasRecruiting at this site
In total, worldwide, 34 of the 119 sites listed in the registry are recruiting; the other 85 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 4, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 4 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.