The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C \[cytarabine\]).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
* Cyclophosphamide * Mesna * Methotrexate * Doxorubicin liposomal * Vincristine * Dexamethasone * Rituximab * Cytarabine
Institute of Hematology "L. & A. Seragnoli"
Bologna, Italy
RECRUITINGType, frequency, severity, timing and relatedness of adverse events (AE)
Time frame: weekly
CR rate after any treatment cycle and at the end of the study
Time frame: monthly
The percentage of hematological responders after any treatment cycle
Time frame: monthly
The percentage of cytogenetic and molecular responders after any treatment cycle in patients for whom genetic markers of minimal residual disease are available
Time frame: monthly
Relapse free survival at month 6 and 12
Time frame: every 6 months
Overall survival at month 6 and 12
Time frame: every 6 months
The percentage of patients submitted to SCT after CR re-induction
Time frame: every 6 months
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