drugset / Trial / NCT01528085

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

NCT01528085

Phase 2 Completed 79 enrolled Goethe University
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-01
Primary completion
2020-03-10
Completion
2020-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule Oral