The goal of this trial is to evaluate the efficacy and the tolerance of the combination of nilotinib with chemotherapy in the front-line setting as induction and consolidation therapy in Ph+ ALL patient aged 55 years and over. A European consensus has been reached to adopt a common chemotherapeutic schedule for patients aged 55 years and over. This schedule will be used in this trial with the addition of nilotinib as concomitant therapy during induction, consolidation and maintenance. The patients will be prospectively monitored for minimal residual disease and bcr-abl tyrosine kinase domain mutations.
Name: Nilotinib
Description: Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)Type: DrugDescription: rate of patients without event
Measure: Evaluation of efficacy of a nilotinib-based induction and consolidation therapy Time: after 12 monthsDescription: The rate of complete haematological remission after induction treatment
Measure: complete haematological remission Time: after induction treatment (week 5)Description: major molecular response defined by a BCR-ABL/ABL < 0.1% in bone marrow
Measure: major molecular response in bone marrowDescription: complete molecular response defined by a BCR-ABL/ABL < 0.001% in bone marrow
Measure: complete molecular responseDescription: The proportion of patients with confirmed undetectable BCR-ABL level with a test sensitivity of at least 4.5 log.
Measure: undetectable BCR-ABL levelDescription: Detection of a T315I or p-loop BCR-ABL TK domain mutation
Measure: T315I or p-loop MutationsDescription: The proportion of patients with molecular relapse or progression
Measure: molecular relapse or progressionDescription: Tolerability as determined by descriptive assessment of adverse events and discontinuation due to treatment-related SAEs
Measure: TolerabilityDescription: (all patients who started treatment)
Measure: Death during induction Time: End of induction (week 5)Single Group Assignment
There is one SNP
T315I or p-loop Mutations. --- T315I ---
Detection of a T315I or p-loop BCR-ABL TK domain mutation. --- T315I ---