The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
Children less than 18 years of age at date of inclusion into the study
Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse)
Patient enrolled in a participating centre
Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) > 10 U/l)
Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
Breast feeding
Charite University, Berlin, Germany
Lead sponsor
Australian & New Zealand Children's Haematology/Oncology Group
Collaborator
St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)
Collaborator
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator
University Hospital, Motol
Collaborator
Rigshospitalet, Denmark
Collaborator
Turku University Central Hospital (co-sponsor, Finland)
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator
Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)
Collaborator
Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)
Collaborator
Ospedale Pediatrico Bambino (co-sponsor, Italy)
Collaborator
Prinses Máxima Centrum (Co-Sponsor Netherlands)
Collaborator
Oslo University Hospital (co-sponsor, Norway)
Collaborator
Wroclaw Medical University
Collaborator
Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)
Collaborator
Karolinska University Hospital Stockholm (co-sponsor, Sweden)
Collaborator
Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)
Collaborator
University Children's Hospital, Zurich
Collaborator
Manchester University NHS Foundation Trust
Collaborator