Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Recruiting now · Phase 2/Phase 3
Conditions studied: Acute Lymphoblastic Leukaemia
In brief
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.
Key facts
- Study ID
- NCT01949129
- Run by
- St. Anna Kinderkrebsforschung
- People needed
- 1800
- Starts
- 2013-04-01
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2024-01-16
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hospital Dr Luis Calvo Mackenna — Santiago, Chile (enrolling)
- Dana Children's Hospital — Tel Aviv, Israel (enrolling)
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) — Brussels, Belgium (enrolling)
- BC Children's Hospital — Vancouver, Canada (enrolling)
- Saint Sophia Children's Hospital BMT Unit — Athens, Greece (enrolling)
- Schneider Children's Medical Center of Israel — Petah Tikva, Israel (enrolling)
- Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie — Graz, Austria (enrolling)
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk, Belarus (enrolling)
- University Hospitals Leuven Kinderhemato-oncologie — Leuven, Belgium (enrolling)
- Hospital for Sick Children University of Toronto Division of Haematology/Oncology — Toronto, Canada (enrolling)
- Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet — Copenhagen, Denmark (enrolling)
- Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki — Helsinki, Finland (enrolling)
- National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit — Budapest, Hungary (enrolling)
- Rambam Medical Center — Haifa, Israel (enrolling)
- Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA — Buenos Aires, Argentina (enrolling)
- Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit — La Plata, Argentina (enrolling)
- Universitätsklinik für Kinder- und Jugendheilkunde — Innsbruck, Austria (enrolling)
- St. Anna Children's Hospital, Vienna, Austria — Vienna, Austria (enrolling)
- Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique — Brussels, Belgium (enrolling)
- University Hospital Gent Pediatrische hemato-oncologie — Ghent, Belgium (enrolling)
- Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman — Liège, Belgium (enrolling)
- CHU Sainte-Justine Hematology-Oncology Division — Montreal, Canada (enrolling)
- Department of Pediatrics, UHC Zagreb — Zagreb, Croatia (enrolling)
- Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University — Prague, Czechia (enrolling)
- A.O. San Gerardo di Monza Clinica Pediatrica — Monza, Italy (enrolling)
Full record on ClinicalTrials.gov
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