A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatmen (EudraCT 2012-004092-40, ClinicalTrials.gov NCT01784068)
Indication and most important inclusion criteria
Chronic myeloid leukemia (CML)
Potential participants should have received treatment with nilotinib for at least 12 months and should have had evidence of typical BCR-ABL transcripts (b3a2 and/or b2a2) at the time of CML-CP diagnosis. Eligible patients should be in MR4.5.
Short description of intervention
The main purpose of the study is to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment.
Nilotinib will be given during the following study phases: consolidation, continuation, prolonged continuation, re-initiation and re-initiation-2 phases.
Type of study
Treatment discontinuation trial
No longer recruiting. The total duration of the study has been extended to 5 year treatment-free remission (TFR).
Novartis Pharma AG
Scientific lead / contact
Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health
Short protocol in European LeukemiaNet
Study centres are participating in the following countries (Further details please access clinicaltrials.gov):