The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
275
Nelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil \>1 Giga/Liter for a maximum of 5 blocks
Hematology
Paris, France
RECRUITINGDisease free survival (DFS)
Time frame: 4 years
Overall survival
Time frame: 4 years
Cumulative incidence of relapse
Time frame: 4 years
Non relapse mortality (NRM)
Time frame: 4 years
Disease free survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Cumulative incidence of relapse censored at allograft in first complete remission (CR)
Time frame: 4 years
Overall survival censored at allograft in first complete remission (CR)
Time frame: 4 years
Non relapse mortality (NRM) censored at allograft in first complete remission (CR)
Time frame: 4 years
Minimal residual disease (MRD)
Time frame: within 1 year
Proportion of patients having received the 5 cycles of nelarabine
Time frame: 3 years
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