ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
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).
ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients [Asia, Europe, North America, South America]
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)
What is the purpose of the study
Nilotinib will be given during the following study phases: consolidation, continuation, prolonged continuation, re-initiation and re-initiation-2 phases.
What will happen during the study
Key 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.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health
Novartis Pharma AG
Scientific lead / contact
Hochhaus, Prof. Dr. med. Andreas
Abteilung Hämatologie und Internistische Onkologie
Study centers / principal investigators
Study centres are participating in the following countries (Further details please access clinicaltrials.gov):