Clinical study on pre-transplant conditioning regimens in acute myeloid leukemia in children
Summary description of the study
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.
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Intervention under investigation
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.
(BASEC)
Disease under investigation
Acute myeloid leukemia
(BASEC)
- 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)
Exclusion criteria
- 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)
Trial sites
Basel, Geneva, Zurich
(BASEC)
Sponsor
Västra Götaland Regionen (Sweden) Schweizerische Pädiatrische Onkologie Gruppe
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Marc Ansari
+41 22 372 47 31
marc.ansari@clutterhug.chHUG Hôpitaux Universitaires Genève
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Geneva
(BASEC)
Date of authorisation
24.06.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Studying Conditioning Regimen In Pediatric Transplantation – AML (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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