Interfant 06 : International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia (Other IDs: CDR0000570260, DCOG-INTERFANT-06, EudraCT 2005-004599-19, CCLG-LK-2006-10).

Trial Identifiers

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• NCT00550992

Scientific Title

International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukaemia (Other IDs: CDR0000570260, DCOG-INTERFANT-06, EudraCT 2005-004599-19, CCLG-LK-2006-10).

Cooperative Group

Dutch Childhood Oncology Group

Summary

Infant acute lymphoblastic leukaemia (ALL) is a rare disease and comprises about 4% of childhood ALL. Whereas the outcome of older children with ALL has improved to 80-85% event-free survival (EFS) infants with ALL have a worse prognosis.In 1999, a large international collaborative study group was started to develop common treatment protocols for infant ALL to try to improve the outcome for these very young children.The primary aim of the study is to assess the role of early intensification of two acute myeloid leukemia induction blocks versus standard IB protocol directly after induction, in a randomised way in MR and HR patients.The secondary aims of the study are:to assess the overall outcome of the Interfant-06 protocol compared to the historical control series, especially the Interfant-99, to assess the outcome of LR, MR and HR patients as compared to the historical control series in Interfant99, to study which factors have independent prognostic value and to assess the role of stem cell transplant (SCT) in HR patients.