Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
The aim of this clinical study in adult ALL is to compare by risk category (1) the
feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free
survival in relation to the achievement of an early MRD negative status and following
consolidation with lineage-targeted methotrexate infusions and other disease-specific
therapeutic elements, with or without the application of allogeneic or autologous SCT
depending on risk class and MRD study results.
In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all
patients receive induction/consolidation therapy incorporating lineage-targeted high-dose
methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the
achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final
consolidation phase.