2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients

• Status: Active, not recruiting
• Trial end date: 2027-09-01

Summary

The main goal of the study is the assessment of duration of major molecular response (MMR) or better at 12 and 36 months after stopping tyrosine kinase inhibitors (TKI) therapy a second or third time in patients with at least three years prior TKI treatment comprising at least two years of nilotinib treatment within this trial and maintained stable MR4 (BCR-ABL ratio <0,01% on international Scale (IS) for at least one year and MR4.5 (BCR-ABL ratio <0,0032% on IS) for at least 6 months:

• who failed a first stop in the EURO-SKI study (standardized criteria)

• who failed a first or second stop outside the EURO-SKI study but would have had fulfilled same eligible criteria and were stopped according to EURO-SKI rules

• who failed a first or second stop outside the EURO-SKI study without fulfilling EURO-SKI rules

• Phase: Phase 2

Details

• Lead Sponsor: European LeukemiaNet
• Collaborators: Heidelberg University; Ludwig-Maximilians - University of Munich