drugset / Trial / NCT01657604

TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study

NCT01657604

Phase 3 Completed 717 enrolled University of Jena
RandomizedParallel-groupOpen-labelDiagnostic

Summary

Advances in Chronic Myeloid Leukemia (CML) therapy led to an expected survival prolongation of \> 20 years after diagnosis. So far, discontinuation of tyrosine kinase inhibitors led to recurrence of disease in the majority of patients. The trial aims to improve treatment strategies in CML by improving induction therapy and deescalating maintenance therapy using low dose IFN as inducer of immunosurveillance. The trial will provide important data on the duration of active therapy in CML patients. Considering the rapidly increasing prevalence of CML this is of individual but also socioeconomic importance.

Timeline

Start
2012-08-24
Primary completion
2022-05-31
Completion
2022-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nilotinib Small molecule 300 mg
Subject Peginterferon α-2b Protein / enzyme biologic 30 ug