Clinical study on pre-transplant conditioning regimens in acute myeloid leukemia in children
Descrizione riassuntiva dello studio
The SCRIPT-AML study is an international clinical study investigating conditioning chemotherapy prior to hematopoietic cell transplantation (HCT) in children, adolescents, and young adults with acute myeloid leukemia (AML). The main objective of the SCRIPT-AML study is to compare the tolerance and efficacy of two different conditioning regimens used in the treatment of AML in children and adolescents. This study consists of different parts: an interventional part that includes randomization (i.e., a random allocation of participants into different groups) and an observational part.
(BASEC)
Intervento studiato
Based on predefined criteria, it will be decided whether the patient can participate in the randomization or the observational arm of the SCRIPT-AML project.
Randomization:
As part of the randomization, the patient will receive one of the following chemotherapy combinations during the conditioning phase prior to HCT:
• BuCyMel: busulfan, cyclophosphamide, melphalan
• CloFluBu: clofarabine, fludarabine, busulfan
Patients will be randomly assigned (randomization) to the two groups. Both combinations have already been successfully used for pre-HCT conditioning in cases of acute myeloid leukemia. The controlled comparison of BuCyMel with CloFluBu in this study will allow for the assessment of whether one of the conditioning protocols is more effective or associated with fewer side effects than the other or whether, conversely, both protocols are equivalent.
Observational arm: Unlike the randomization, in the observational arm, the treating physician will decide on the chemotherapy combination administered during the pre-HCT conditioning phase.
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Malattie studiate
Acute myeloid leukemia
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- Children ≤ 18 years at the time of diagnosis and ≤ 21 years at the time of HCT, diagnosed with - AML and having an indication for HCT according to the protocol, with - an acceptable HLA-compatible stem cell donor and in hematological remission at the time of HCT. (BASEC)
Criteri di esclusione
- Secondary AML or primary refractory disease requiring "off-protocol" treatment - Excessive risk of toxicity (such as Down syndrome, Fanconi anemia) - Previous stem cell transplantation (BASEC)
Luogo dello studio
Basilea, Ginevra, Zurigo
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Sponsor
Västra Götaland Regionen (Sweden) Schweizerische Pädiatrische Onkologie Gruppe
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Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Marc Ansari
+41 22 372 47 31
marc.ansari@clutterhug.chHUG Hôpitaux Universitaires Genève
(BASEC)
Informazioni scientifiche
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Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
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Data di approvazione del comitato etico
24.06.2024
(BASEC)
ID di studio ICTRP
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Titolo ufficiale (approvato dal comitato etico)
Studying Conditioning Regimen In Pediatric Transplantation – AML (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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