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Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)

Heike Pfeifer, Dr.med.

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.

Evaluation of Efficacy and Safety of Nilotinib in Combination With Chemotherapy in Elderly Patients With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)

The rate of complete haematological remission after induction treatment

major molecular response defined by a BCR-ABL/ABL \< 0.1% in bone marrow

complete molecular response defined by a BCR-ABL/ABL \< 0.001% in bone marrow

The proportion of patients with confirmed undetectable BCR-ABL level with a test sensitivity of at least 4.5 log.

Detection of a T315I or p-loop BCR-ABL TK domain mutation

The proportion of patients with molecular relapse or progression

Tolerability as determined by descriptive assessment of adverse events and discontinuation due to treatment-related SAEs

Goethe University

Dr.med.

Spots Global Cancer Trial Database for philadelphia chromsome