Spots Global Cancer Trial Database for Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
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Trial Identification
Brief Title: Studying Conditioning Regimen In Pediatric Transplantation - AML , SCRIPT-AML
Official Title: A Randomized, Multi-Center Phase III Trial Comparing Two Conditioning Regimens (CloFluBu and BuCyMel) in Children With Acute Myeloid Leukemia Undergoing Allogeneic Stem Cell Transplantation.
Study ID: NCT05477589
Study Description
Brief Summary: 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)
Detailed Description: The study is designed as an open-label randomized phase III, multicenter superiority trial comparing two conditioning regimens CloFluBu and BuCyMel in children with acute myeloid leukemia (AML) with per-protocol indications to allogeneic hematopoietic stem cell transplantation with a myeloablative conditioning. This study is composed of two parts - an interventional part that includes randomization, and an observational part. The interventional part is a phase III randomized, open label, multicenter parallel group trial comparing two conditioning regimens used in pediatric HCT: a three alkylator combination of busulfan, cyclophosphamide and melphalan (BuCyMel, standard arm) and a combination of clofarabine, fludarabine and busulfan in which two alkylators are replaced by antimetabolites (CloFluBu, experimental arm). The observational part will prospectively register outcome measures of transplantation in patients not fulfilling criteria for participation in the interventional part of the study (due to lack of complete remission, lack of matched sibling or unrelated donor, who were not recruited to a national upfront protocol or who decline participation in randomization) but consenting to registration of the data.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
L'Hôpital Universitaire des Enfants Reine Fabiola (HUDERF), Brussels, , Belgium
Cliniques Universitaires Saint-Luc (CUSL), Brussels, , Belgium
Department of Pediatric Hematology, Oncology and SCT, Ghent University Hospital, Ghent, , Belgium
University Hospital Leuven, Leuven, , Belgium
Centre Hospitalier Régional de la Citadelle (CHR)/CHU Liège, Liège, , Belgium
Paediatric Stem Cell Transplant and Immune Deficiency, Department of Pediatric and Adolescent Medicine, Section 4072, Rigshospitalet University Hospital of Copenhagen, Copenhagen, , Denmark
Division of Hematology, Oncology, and Stem Cell Transplantation, The New Children's Hospital, Helsinki University Hospital, Helsinki, , Finland
Department of Pediatrics and Adolescent Medicine, Hong King Children's Hospital, Hong Kong, , Hong Kong
Schneider Children's Medical Center of Israel, Petach Tikva, , Israel
Vilnius University Hospital Santaros Klinikos Center for Pediatric Oncology and Hematology, Vilnius, , Lithuania
Princess Máxima Center for Pediatric Oncology, Utrecht, , Netherlands
Department of Pediatric Hematology and Oncology, Oslo University HospitalOslo University Hospital, Oslo, , Norway
Stemcelltransplant unit Hospital Niño Jesús, Madrid, , Spain
Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, , Sweden
Barncancercentrum, avdelning 64, Skane University Hospital, Lund, , Sweden
Pediatric Hematology immunology and stem cell transplantation Astrid Lindgren children's Hospital Huddinge K86-88, Stockholm, , Sweden
Childrens department for Blood and tumor diseases Uppsala University Hospital, Uppsala, , Sweden
Contact Details
Name: Karin Mellgren, Prof. MD
Affiliation: Sahlgrenska University Hospital, Gothenburg, Sweden
Role: STUDY_CHAIR
Name: Birgitta Versluys, MD, Phd
Affiliation: Princess Máxima Center for Pediatric Oncology, Utrecht, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
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