ENESTFreedom = Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients

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

Novartis Oncology

Principal investigator

Hochhaus, Prof. Dr. med. Andreas
Universitätsklinikum Jena
Abteilung Hämatologie und Internistische Onkologie

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