Information booklet for patients and parents for download
Acute lymphoblastic leukaemia (ALL) is the most common malignant disease in childhood with an incidence of 4/100.000 children per year in Europe.
Over the past 4 decades, survival has improved from less than 20% to over 80%.
About 15-20% of patients suffer a relapse of the disease, resulting in an incidence of about 0.7/100.000 children per year in Europe. With the use of intensive combination chemotherapy and haematopoietic stem cell transplantation (HSCT), currently 40-50% of the children with ALL relapse can be cured.
However, a substantial part of patients still relapse after highly intensive chemotherapy and allogeneic stem cell transplantation (allo-SCT), which suggests that alternative strategies are required, because ALL relapse is still one of the most frequent causes of death in childhood malignancies.
Though survival of children with acute lymphoblastic leukaemia (ALL) has improved, relapse remains a leading cause of mortality in childhood cancer. Given the rarity of the disease, only a large international cooperative group can recruit sufficient patients for further studies with specific questions in biologic subgroups. Under the umbrella of the I-BFM SG all relevant mainly European study groups are creating the worldwide largest Study for Children with Relapsed ALL (IntReALL 2010).
The aim is to develop optimized standard treatment as a platform for systematic randomized phase II and III studies (*a) on the most promising new and targeted agents. An adequate trial structure, an optimized web based database, and standardized diagnostic methods need to be established.
Patients are stratified into a standard (SR) and a high risk (HR) group according to established factors. For SR patients, the best available treatment protocols ALL-REZ BFM 2002 and ALL R3 are randomly (*b) compared, and the additional effect on survival of the humanized monoclonal CD22 directed antibody (*c) epratuzumab is investigated. HR patients who have unsatisfying remission rates will receive an intensified induction with the new nucleoside (*d) analogue clofarabine compared to standard induction therapy. IntReALL 2010 allows for comprehensive tumour banking and systematic biologic research in subgroups with correlation to clinical outcome. SMEs will be involved into project management, data base development, and pharmaceutical and biotechnological research to ensure innovation in the respective areas.
IntReALL 2010 is embedded in a network of European academic structures relevant for childhood cancer. It will be a cornerstone of drug development in childhood leukaemia and the only trial with the potential for well powered phase III studies in this indication.
IntReALL 2010 will harmonize ALL-relapse therapy, establish highest diagnostic and therapeutic standard and improve survival of children with ALL.
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*a Phase II trial confirms the tolerability and efficacy of a drug in an early phase of development and a rather small cohort, phase III investigates efficacy and tolerability in context / comparison with established standard therapy in a large cohort of patients.
*b Allocation by chance, allowing for a statistically valid comparison of two treatment arms
*c Most of the antibody is human and thus does not cause allergic/immunologic reactions, monoclonal means one single type of antibody, CD 22 is a protein expressed on the surface of leukemic cells, the antibody binds specifically to this protein.
*d Nucleoside is an essential element of the DNA structure, nucleoside analoga are modified ’false’ elements which being incorporated into the DNA lead to DNA damage and cell death.
Find more information for patients and parents at IntReALL partner >> CCI
