ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
Type of study
Treatment discontinuation trial
Current status
No longer recruiting. The total duration of the study has been extended to 5 year treatment-free remission (TFR).
Study title
ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients [Asia, Europe, North America, South America]
Scientific title
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.
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
Study sponsor
Novartis Pharma AG
Scientific lead / contact
Hans Menssen
hans.menssen@novartis.com
Novartis Oncology
Principal investigator
Hochhaus, Prof. Dr. med. Andreas
Universitätsklinikum Jena
Abteilung Hämatologie und Internistische Onkologie
andreas.hochhaus@med.uni-jena.de
Study centers / principal investigators
Study centres are participating in the following countries (Further details please access clinicaltrials.gov):
Argentina
Austria
Belgium
Bulgaria
Colombia
Denmark
France
Germany
Greece
Hungary
Ireland
Italy
Japan
Netherlands
Poland
Spain
Sweden
UK
United States