drugset / Trial / NCT01657604
TKI and Interferon Alpha Evaluation Initiated by the German Chronic Myeloid Leukemia Study Group - the TIGER Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nilotinib | Small molecule | 300 mg | — |
| Subject | Peginterferon α-2b | Protein / enzyme biologic | 30 ug | — |