NCT01528085

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia

Interventions

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

Timeline

• Start date: 2012-01-01
• Primary completion: 2020-03-10
• Completion: 2020-03-10
• First posted: 2012-02-07
• Last updated: 2020-07-30

Locations

69 sites across 3 countries: France, Germany, Spain