Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorVastra Gotaland Region
About this trial
It is a randomized phase 3 study comparing two conditioning regimens in children with Acute Myeloid Leukemia, AML, undergoing allogenic stem cell transplantation. The primary aim is to investigate if a conditioning regimen containing one alkylator (Bu) combined with two antimetabolites (Clo and Flu) results in superior 2-year acute grade III to IV-free, chronic non-limited GvHD-free, relapse free survival than a conditioning regimen combining three alkylating agents (BuCyMel)
Eligibility criteria
Qualifiers
Age ≤18 years at time of initial AML, age ≤ 21 years at transplantation.
HCT is performed in a study participating center
All women of childbearing potential who have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
Signed informed consent.
Disqualifiers
Diagnosis of myelodysplastic syndrome (MDS).
Diagnosis of juvenile myelomonocytic leukemia (JMML).
History of previous malignancy (AML diagnosed as secondary cancer).
Known diagnosis of Fanconi anemia.
Trial design
Treatments tested in this trial
- busulfan, cyclophosphamide and melphalan, BuCyMel
- clofarabine, fludarabine and busulfan, CloFluBu
Treatment groups
170 Participants
are divided into 2 treatment groupsLocations
17Belgium
Cliniques Universitaires Saint-Luc (CUSL)1200, Brussels Belgium
L'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)1020, Brussels Belgium
Department of Pediatric Hematology, Oncology and SCT, Ghent University Hospital9000, Ghent Belgium
University Hospital Leuven3000, Leuven Belgium
Sponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Source ClinicalTrials.gov