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)
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
Current status
No longer recruiting. The total duration of the study has been extended to 5 year treatment-free remission (TFR).
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
Additional information
Study description in the US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health
Short protocol in European LeukemiaNet
Study centers
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
Minimal residual disease
A type of deep remission in CML where BCR-ABL is however still detectable by PCR
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
Protocol
The action plan for the research work, which explains key objectives and procedures. In case of a clinical trial, the protocol defines e.g. the purpose of the study, how many people will participate, eligibility criteria, the medical intervention, etc.
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
MR4.5
Molecular response, or molecular remission, with a reduction of 4.5 log (BCR-ABL <0,0032%)
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
MR4
Molecular response, or molecular remission, with a reduction of 4 log (BCR-ABL <0,01%)
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
TFR
Abbreviation for Treatment-Free Remission. In CML is referred to having a stable deep molecular response without the need for ongoing Tyrosine Kinase Inhibitor (TKI) treatment after having been in deep molecular residual disease over a longer period of time.
TFR
Abbreviation for Treatment-Free Remission. In CML is referred to having a stable deep molecular response without the need for ongoing Tyrosine Kinase Inhibitor (TKI) treatment after having been in deep molecular residual disease over a longer period of time.
