ALL-REZ Registry

Relapse of acute lymphoblastic leukaemia

Registry / Observational Study

• If possible, complete registration of all children and adolescents with a first or further relapse of ALL (who do not participate in the IntReALL HR trial)
• Continuation of etablished refererence diagnostics and biobanking
• Ensuring long-term follow-up of patients

By recording all children and adolescents with an ALL recurrence as thoroughly as possible within an assigned registry, epidemiological evaluations can be made about the incidence, course and prognosis of these patients. The disease group of relapsed ALL contributes to the mortality of children and adolescents with malignant diseases like no other. The registry protocol provides guidelines for systematic follow up of patients, subsequently enables early diagnosis and management of late effects, which are recorded and correlated with previous therapies and clinical factors. Corresponding risks can be taken into account for future treatment design. As a competence centre for relapsed/refractory ALL, the study centre advises participating centres on special issues regarding individual therapy strategies as well as the indications for radiotherapy and stem cell transplant. Regarding treatment, patients with relapsed and/or refractory ALL can be advised and referred accordingly in an open-label AMG study.

The therapy instructions included in this protocol do not provide recommendations for generally accepted treatment in their current version, but are rather considered as treatment guidelines. The risk groups S1 to S4 are defined according to the ALL-REZ BFM 2002 trial. The only change made to these definitions is the classification of very early isolated extramedullary recurrences in the S4 group. Due to the good results of the ALL-REZ BFM 2002 study, treatment according to the ALL-REZ BFM 2002 protocol is still recommended for children and adolescents with a first ALL recurrence until the new international ALL recurrence study opens. Consolidation is carried out using Protocol II-Ida. In the event of a subsequent recurrence, it is recommended to consult the study centre.

• Diagnosis of ALL recurrence (immunophenotype B precursor or T, isolated or combined medullary or extramedullary) in patients ≤ 18 years of age
• Registry:
• Consent to data sharing if long-term follow-up is possible
• Tumorbanking:
• Consent to tumour banking and biological accompanying examination